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Articles Tagged "compliance"

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 »

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 »

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 »

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 »

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 »

Master Your Sterilization Process

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New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices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FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance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 »

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 »

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 »

Sunshine Act and Beyond: Improving Compliance

by Vahan Minassian | 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 »

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 »

Get Ready for UDI: It’s All About the Data

by BONEZONE | Mar 2013

Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex nature of UDI means OEMs can’t wait for the final announcement to put processes in place.... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | 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 »

Blogs and Apps that Bring Solutions

by BONEZONE | Dec 2012

UPDATE: Mr. Packard's blog has moved to Medical Device Academy. Also, find his BONEZONE articles  by clicking on the author tab on the homepage. Quality Control can be stale. Reading about it can be even duller. Rob Packard wants to change that by bringing the topic to life with his blog, QC i... 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 »

Unique Device Identification: From Compliance to Value

by BONEZONE | Oct 2012

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database. Orthopaedic manufacturers will be among the first impacted... Read more »

Complaints: A Second Chance to "Make it Right"

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 »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

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 »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

Planning for the Unpredictability of Change

by BONEZONE | Dec 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 »

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 »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

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 »