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: EU MDR
How Are Medical Device Companies Addressing EU MDR?
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
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.
Preparing for MDR: Partner Up
There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
EU MDR: Changing World of Classification
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
EU MDR, UDI and Master Data: How to Ensure Label Compliance
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
UDI Implementation: Progress, Challenges, Where We Are Now
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Top 10: EU MDR Remains a Hot Topic in 2019
MedTech Intelligence readers continue to crave information about the new regulation.
Regulatory Reporting: What can Medical Device Manufacturers Learn from Big Pharma?
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
Now You’re Speaking My Language: Modernizing Instructions for Use to Comply with MDR
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
