When Do I See a CAPA Specialist?
If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we...
May 08 2017,
Regulations
Design Intent: Do I Need to Perform Verification and Validation?
If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs...
Apr 11 2017,
Clinical Data and CE Mark: What are We Doing Wrong?
A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process,...
Mar 27 2017,
Once an Easy Path, Europe’s Regulatory Approval Toughens
Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval....
Mar 07 2017,
FDA Update: Final Guidance on Medical Device Reporting
FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is...
Jan 11 2017,
How Often Should You Audit Your Suppliers?
EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing...
Jan 10 2017,
A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens
Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle...
Jan 10 2017,
One Answer to Your Postmarket Challenge: Planning
Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests...
Dec 07 2016,
Building Your Bridge to the Island of ISO 13485:2016
Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The...
Nov 22 2016,
Clinical Data: A Snapshot of Recent Announcements
Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or...
Nov 09 2016,
Class II Design Problem Solved with Simulation
Many articles generalize design controls, but few provide direct application. This article offers a broad overview for engineers and their managers...
Oct 07 2016,
Reimbursement in Spine: A NASS Priority
In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making...
Sep 07 2016,
Resubmitting a 510(k) is More Than a Regulatory Decision
Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis...
Sep 07 2016,
Making the Most of UDI
UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own...
Aug 04 2016,
FDA Guidance Outlines How to Create a Unique Device Identifier
FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier....
Jul 26 2016,