Survey: 75% MedTech Pros Unprepared for an Unannounced FDA or Notified Body Audit
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Tag Archives: regulatory
FDA “First” Approvals: Pediatric Lens for Myopia and Duodenoscope with Disposable Elevator
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
Global Medtech M&A Deals Hit $1.85 Billion in August
The total value of deals for 2019 exceeds $30 billion.
Biotronik’s EU MDR Certification a ‘Huge Milestone’, Says GlobalData
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
Technical Writing Workshop Focuses on Key Elements for Lifescience Companies
This two-part virtual workshop will guide participants through the process of how to write effective documents.
The Impact of Regulatory Requirements on Bringing Medical Devices to Market
If you’re looking to market your medical device, there are many tasks to complete.
Supplier Quality Considerations For Quality and Regulatory Service Providers
When outsourcing these key functions, asking the right questions will help minimize the risk.
The Ultimate QA/RA Cheat Sheet
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
What Guidance Documents Will CDRH Issue in 2017?
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
CDRH Releases FY 2017 Regulatory Priorities
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.
