Clinical Trials Shift to Hybrid Approaches in the Age of COVID-19 and Beyond
Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future. ...
Nov 24 2020,
Regulations
How to Take a Risk-Based Approach to Biocompatibility
The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks...
Nov 16 2020,
MDR Experts Share How to Successfully Navigate the Requirements
Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice...
Oct 30 2020,
Considerations for Your Device’s Manual and Mechanical Cleaning Validations
Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated...
Sep 30 2020,
4 Human Factors Practices that Lead to Successful FDA Submission
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not...
Sep 22 2020,
FDA Update: Inspections Return, De Novo Classification and ISO 13485 Added to Agenda
FDA has made multiple announcements in recent weeks, including the return of domestic inspections as well as decisions on De...
Jul 21 2020,
FDA Repeats Call for Advanced Manufacturing Efforts
FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC...
Jul 08 2020,
How to Incorporate Software Validation in Your Device Design and Quality Processes
In our latest Ask the Expert article, we answer how software validation fits with your SOPs for design validation and...
May 25 2020,
How Will FDA’s CDRH Reorganization Impact Me?
The goal of the CDRH reorganization was to drive operational efficiencies. Some organizations will feel the impacts of changes more...
May 12 2020,
EU MDR Postponement Clears Another Hurdle
The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ...
Apr 21 2020,
COVID-19: What CDRH Wants You to Know about Regulatory Submissions and Clinical Trials
FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the...
Mar 25 2020,
MDR Deadline Still On—for Now
The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others...
Mar 24 2020,
How to Approach Risk Management Under ISO and MDR Updates
Question: How do I handle medical device risk management and the change from ALARP to AFAP? Virginia Anastassova of StarFish...
Mar 05 2020,
Arthroscopy Pumps Targeted in New FDA Guidance
FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of...
Feb 10 2020,
ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management
The medical device risk management standard was updated to better align with changes in medical device regulations around the world....
Jan 20 2020,