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Articles Tagged "FDA"

Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody

by BONEZONE | Jul 2019

The next-generation system was designed to improve simplicity and ease of use for minimally invasive lumbar procedures, and is part of a lumbar fusion solution suite that also includes Orbit discectomy instruments.   ... Read more »

FDA's Pre-Submission Process Allows You to Minimize Risk and Decrease Cost

by BONEZONE | May 2019

Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly reduce the risk of delays once a 510(k) is under review.... Read more »

ChoiceSpine Granted FDA Clearance for New Cervical Spinal Fusion Devices

by BONEZONE | May 2019

With these 510(k)s in hand, TIGER SHARK C Cervical Interbody and BOOMERANG Anterior Cervical Plate are set to enter the robust spinal implant market.   ... Read more »

FDA 510(k) Recap: Shoulders and Ankles

by BONEZONE | May 2019

Shoulders and ankles comprise the largest share of the extremities joint reconstruction segment. Arthrex, Catalyst OrthoScience, DJO, Exactech, Stryker and Zimmer Biomet have continued to grow their offerings of these devices in 2019 to keep extremities replacement momentum going.    ... Read more »

FDA Finalizes Guidance for UHMWPE used in Orthopedic Devices

by BONEZONE | May 2019

FDA released guidance regarding the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices, providing manufacturers direction in determining the appropriate testing needed for regulatory submissions.... Read more »

Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion

by BONEZONE | May 2019

NanoBone Bone Graft used as a standalone in posterolateral spinal fusion may represent a significant advancement in patient care. Eliminating the need to mix synthetic graft with autograft or to harvest and concentrate bone marrow aspirate can offer savings of time and money, and can ... Read more »

Konica Minolta Healthcare Gains FDA Clearance for Dynamic Digital Radiography

by BONEZONE | May 2019

Today, orthopedists rely on external motion and static x-ray to assess joint stability and spinal movement. With DDR, orthopedists and musculoskeletal specialists can acquire a full view of the skeletal system in supine and prone positions to view changes in the bone and articulations throughout the... Read more »

Brainlab Recalls Spine & Trauma 3D Navigation Software

by BONEZONE | Apr 2019

The recalled software is used with Brainlab's navigation system during spinal and trauma procedures, providing patient images to navigate surgical tools and implants used before and during minimally invasive procedures. FDA has identified this as a Class I recall.   ... Read more »

FDA 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms

by BONEZONE | Apr 2019

Orthopedic companies large, mid-sized and small are gaining FDA clearance for products in new materials, and made with attractive manufacturing methods like 3D printing. Companies like Kuros Biomedical and Nvision are making strategic decisions to move into adjacent markets. ... Read more »

FDA Clarifies 510(k) Pathway for Bio-Gate’s Silver Antimicrobial Coating

by BONEZONE | Jan 2019

Bio-Gate learned during its FDA pre-submission process that a 510(k) application can be submitted without human data for its HyProtect™ thin plasma coating that contains pure silver and polysiloxane and protects implants against bacterial colonization.... Read more »

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

by BONEZONE | Dec 2018

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."... Read more »

FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program

by BONEZONE | Dec 2018

In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity, including updating previous guidance, a new cybersecurity playbook and a program with the Department of Homeland Security.... Read more »

FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap

by BONEZONE | Nov 2018

Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »

How to Respond to FDA Inspection Observations, Even Those You Dispute

by BONEZONE | Oct 2018

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."... Read more »

25 Considerations for Companies Seeking Clarity in Design Controls

by BONEZONE | Sep 2018

OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices are often the result of informal development that does not ensure proper establishment and assessment of these requirements. ... Read more »

510(k) Recap: New Products from Companies You Know

by BONEZONE | Aug 2018

We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth.... Read more »

FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing

by BONEZONE | Aug 2018

An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and... Read more »

Making a Device Design Change? Document These Critical Steps

by BONEZONE | Jun 2018

No matter where you are in the design process and no matter your internal procedures, control and documentation of design change is critical for safe and effective products.... Read more »

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie Vetalice | Jun 2018

To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.... Read more »

Empirical Machine Earns FDA Contract Manufacturer Registration

by BONEZONE | Jun 2018

The company is now approved to craft medical devices in addition to prototyping and small-batch manufacturing.... Read more »

coflex Gains Disposable Instrument PMA, NASS Coverage Policy Recommendation

by BONEZONE | May 2018

These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles.... Read more »

MCRA Presents on Medical Device Regulation to Chinese FDA

by BONEZONE | May 2018

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process.... Read more »

ConnectSx Launches Free Inventory App for Sales Reps

by BONEZONE | Apr 2018

The iOS-native mobile app brings transparency to the surgical supply chain by helping users schedule cases, manage inventory, track UDI data and generate billing documents.... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by BONEZONE | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

Gauthier Biomedical Gains FDA Clearance for Intellitorq Electronic Torque Indicating Driver

by BONEZONE | Mar 2018

The company is the first to receive 510(k) clearance for an electronic torque indicating device.... Read more »

Medical Device Packaging is Shaped by Increased Regulations

by BONEZONE | Mar 2018

Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years.... Read more »

Are You Capturing the Right Inspection Information?

by BONEZONE | Feb 2018

By recording actual results, instead of pass/fail, you can better investigate failures that may occur in production/post-production. This approach also helps to verify the specification you originally developed is appropriate and effective for your products.... Read more »

FDA Issues First De Novo Clearance Under Orthopaedic Panel

by BONEZONE | Jan 2018

IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.... Read more »

ConnectSx Launches UDidentify Mobile App

by BONEZONE | Jan 2018

The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI)... Read more »

FDA Finalizes Additive Manufacturing Guidance

by BONEZONE | Dec 2017

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.... Read more »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »

Examining Methods to Determine Sample Sizes

by BONEZONE | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... Read more »

CAPA Notes from an FDA Inspection

by BONEZONE | Oct 2017

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.... Read more »

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

by BONEZONE | Jun 2017

While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing product from the market. Begin by knowing the leading causes of recalls.... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by BONEZONE | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... Read more »

FDA 510(k) Insights: March Clearance Highlights

by BONEZONE | Apr 2017

Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... Read more »

Design Intent: Do I Need to Perform Verification and Validation?

by BONEZONE | Apr 2017

If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs or outputs, do you have to formally perform verification and validation? Our experts respond.... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.... Read more »

How Often Should You Audit Your Suppliers?

by BONEZONE | Jan 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight.... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by BONEZONE | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »

FDA Guidance Outlines How to Create a Unique Device Identifier

by BONEZONE | Jul 2016

FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier.... Read more »

Methods 3D Adds New 3D Printer

by BONEZONE | May 2016

Methods 3D, a subsidiary of Methods Machine Tools, announced the addition of the ProJet® MJP 3600 to its line of 3D printers and direct metal 3D printers from 3D Systems. Methods 3D has installed the ProJet MJP 3600 within its multiple technology centers across the U.S. to provide product demonstr... Read more »

FDA Issues Draft Guidance on Additive Manufactured Devices

by BONEZONE | May 2016

FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices.... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

New Guidance for UHMWPE Submissions

by BONEZONE | Feb 2016

FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene (UHMWPE) for approval. ... Read more »

A Look at FDA’s 2016 Priorities, Status of 2015 Priorities

by BONEZONE | Jan 2016

FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review.... Read more »

Adaptive Designs Provide Clinical Trial Flexibility

by Hannah Corcoran | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Ruled a Requirement for EHRs

by BONEZONE | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

NASS Recap: Surface-treated, 3D-printed Cages among New Launches in Interbody Space

by Carolyn LaWell | Nov 2015

Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Orchid Design Selected to Participate in FDA’s Submission Tracker Pilot Program

by BONEZONE | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline.... Read more »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Mobile Medical Apps Attract OEM, FDA Attention

by Prithul Bom, MBA, RAC | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CAPA+2, UDI and More: What to Expect from FDA in 2015

by Hannah Corcoran | Feb 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

by BONEZONE | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Focuses on Properties and Biocompatibility of AM Medical Devices

by Hannah Corcoran | Nov 2014

Understand FDA’s current thinking on the regulatory process for additive manufactured devices.... Read more »

FDA Surveillance Inspections and Warning Letters Decrease

by Hannah Corcoran | Nov 2014

A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action items to avoid quality issues.... Read more »

FDA Publishes Q&A on UDIs

by BONEZONE | Sep 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Turner Medical Reports Zero Findings in FDA Audit

by BONEZONE | Jul 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Six Ways to Prevent Supplier Quality Problems

by Robert Packard | Jun 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Implementation: What are Your Next Steps?

by Jonathan Bretz | Jun 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Expectations: Overcoming Supply Chain Weaknesses

by Martin Browning | Apr 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How Far is “Possible” for Risk Management?

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Five Ways to Prevent Complaint Handling Pitfalls

by Robert Packard | Mar 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Webinar: Making Your Management Review Meetings More Effective

by BONEZONE | Mar 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Promotes Voluntarily Correcting Violations with New Program

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Mindfulness Training Adopted to Reduce Errors

by Max Sherman | Dec 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Device Company Questions Answered

by Robert Packard | Dec 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Finalizes UDI Requirements

by BONEZONE | Sep 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Announces Final Rule for Unique Device Identification System

by BONEZONE | Sep 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Postmarket Studies in Lieu of Clinical Trials

A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Looking Back at INFUSE: 2002 to Today

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Voices from OMTEC 2013

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

China Becomes Vastly Improved Player

by John Gagliardi | Jul 2013

China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand their business need to understand the changing industry.... Read more »

How to Avoid Major FDA Inspection Mistakes

by Robert Packard | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Update: Prepping for the Final Ruling

by Karen Conway | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Imaging in Medical Device Manufacturing

by Tim Kulbago | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies

by Marcy Rogers | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Accutek Weighs In on the State of Testing

by BONEZONE | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Basics: A Look at the French Medical Device Market

by BONEZONE | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »