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: quality
Quality and Software Issues Remain Top Reasons for Medical Device Recalls
The number of recalls also increased 21.5% this quarter, according to Stericycle’s Q3 2019 Recall Index.
Global Medtech M&A Deals Hit $1.85 Billion in August
The total value of deals for 2019 exceeds $30 billion.
FDA Monitoring Potential Device Shortage After Atlanta Sterigenics Facility Temporarily Closes
Will more medical devices be impacted?
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.
Advanced CAPA Conference Digs Deep into Challenges and Root Cause Analysis
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Best of 2018 in MedTech
Here are the most read articles of the year.
Supplier Quality Considerations For Quality and Regulatory Service Providers
When outsourcing these key functions, asking the right questions will help minimize the risk.
EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
