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Articles Tagged "regulatory"

Flex-Cell Precision Gains ISO 13485:2016/9001:2015 Certifications

by BONEZONE | Oct 2018

Flex-Cell is a contract manufacturer of orthopaedic implants and surgical components.... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by BONEZONE | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... 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 »

NASS Preview: 14 Spine Products That Caught Our Attention

by BONEZONE | Sep 2018

Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations on PEEK and titanium and more expandable interbody designs. The 14 companies highlighted are already on board.... Read more »

North Grove Enterprise adds Kapstone Medical as Service Provider

by BONEZONE | Sep 2018

Kapstone Medical is a product development service provider and medical device engineering firm.... Read more »

LaVezzi Precision Receives ISO 13485:2016 Certification

by BONEZONE | Sep 2018

This certification is part of the company’s continuing efforts to upgrade its Quality Management System.... 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 »

Final Patient Treated in NUsurface Artificial Meniscus Trials

by BONEZONE | Jul 2018

Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.” ... Read more »

Supply Chain Quality Panel, Part I: OEM and Supplier Perspectives

by BONEZONE | Jun 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts. ... 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 »

Zimmer Biomet Responds to FDA Form 483

by BONEZONE | Jun 2018

The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf of the investigators, a lack of context and incomplete information reported by company representatives.... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by BONEZONE | Jun 2018

Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... 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 »

NN Life Sciences Facility Receives MDSAP Certification

by BONEZONE | Apr 2018

This will allow NN Life Sciences to sell more of its products into new markets using its existing regulatory program.... 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 »

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 »

Vital Validation Considerations for Your Company's Next Packaging Project

by BONEZONE | Mar 2018

Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails. ... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by BONEZONE | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... 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 »

J-Pac Medical Receives ISO:13485:2016 Registration Ahead of Schedule

by BONEZONE | Dec 2017

ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making.... 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 »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

by BONEZONE | Dec 2017

The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

Incipio Devices Expanding, Adding Personnel

by BONEZONE | Nov 2017

The orthopaedic device company is investing more than $7 million in manufacturing and research.... Read more »

Grace College and OrthoWorx Update Orthopaedic Graduate Studies Program

by BONEZONE | Oct 2017

After six years of successful operation and more than 100 graduates of ORCA, it was time to revise the program.... 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 »

Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers

by BONEZONE | May 2017

As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S. based Onyx Medical in 2015, effectively establishing a presence in the largest orthopaedic market.... Read more »

Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote

by BONEZONE | Apr 2017

Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive.... Read more »

How to Reduce Cost and Lead Times While Maintaining Margins

by BONEZONE | Apr 2017

OEMs and suppliers can reduce cost and lead times while preserving or improving margins with numerous initiatives that don't require material or design changes. Simply commit to a cost-focused collaboration that is incorporated into the terms of a master supply or service agreement.... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »

Ovation Awards: MedTorque and Regulatory Compliance Associates

by BONEZONE | Nov 2016

The Ovation Awards recognize growth, success and contributions to the Kenosha, Wisconsin area and its economic development.... Read more »

Spine Company 510(k)s from 1H16

by Julie Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... 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 »

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 »

CoorsTek Acquires Philips’ Ceramics Operation in the Netherlands

by BONEZONE | Jun 2016

CoorsTek has acquired Philips’ ceramics operations in Uden, The Netherlands. Through this acquisition, CoorsTek expands its strategic partnership with Philips and will serve both Philips and other regional customers from Uden. Adding Uden extends the CoorsTek footprint to a dozen European ma... Read more »

Lucideon and STC Offer Wear and Medical Device Testing Seminars in China

by BONEZONE | Apr 2016

Lucideon, a materials technology company, and Hong Kong Standards and Testing Centre (STC), a testing, inspection and certification organization based in Hong Kong and China, are offering a series of seminars on wear testing and medical device testing to orthopaedic implant manufacturers and their s... 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 »

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 »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 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 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 »

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 »

EU Proposes Significant Changes for Importers and Distributors

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 »

Why Won’t My CAPA Process Work?

by John Gagliardi | 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

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 »

Choosing Materials in a Shifting Global Regulatory Environment

by BONEZONE | Aug 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 »

Effective Tools for Patent Searches

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 »

The Starting Line: Turning the Corner with a Device Concept

by John Gagliardi | 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 »

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 »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

Evonik Reaches Milestone with Permanently Implantable VESTAKEEP PEEK

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 »

Sites Medical Expanding in Whitley County, Indiana

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 »

Looking Ahead to 2014

by BONEZONE | 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 »

Empirical Testing: Celebrating 15 Years with Expansion of Services

by BONEZONE | Oct 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 »

ORTHOWORLD Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC)

by BONEZONE | Apr 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 »

Ceram Adds Biocompatibility Testing to its Analysis Services

by BONEZONE | Mar 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 »

Grace College Set For New Year of Orthopaedic Master's Program

by BONEZONE | Feb 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 Quality Review Board: A Conduit for Success

by John Gagliardi | Dec 2012

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 Planning for Regulatory Compliance

by Robert Packard | Dec 2012

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 »

Aptiv Solutions Opens New Office in North Carolina

by BONEZONE | Nov 2012

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 »

Ceram Launches Regulatory Approval Package

by BONEZONE | Oct 2012

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 Draft Guidance: Refuse to Accept 510(k) Policy

by BONEZONE | Oct 2012

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 to Guide Device Makers on Marketing Application

by BONEZONE | Aug 2012

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 - The Fly in the Ointment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

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 Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

by Allyn Decker | Jun 2012

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 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Sep 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by BONEZONE | Aug 2011

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 »

Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

by BONEZONE | Jun 2011

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 »

Blogs and Apps That Bring Solutions

by BONEZONE | Jun 2011

  InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application;  Emergo Group Medical Device Blog for QA/RA Professionals;  IMARC Research Blog... Read more »

Basic Anatomy of a Design Dossier

by BONEZONE | Mar 2011

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 »

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by BONEZONE | Dec 2010

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 Benefits of Capturing Product Data Are High - The Costs of Doing So Don’t Have to Be

by BONEZONE | Dec 2010

Co-authored by Keith Kennedy Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »

MDD Regulations: What I Wish I Had Known

by BONEZONE | Sep 2010

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 »