Featured Product In Quality
Biological Risk Evaluation and Management for Medical Devices
$397.00
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. Read More
Quality
Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript
$287.00
Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript
$287.00
Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript
$287.00
FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers
$287.00
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
$287.00
FDA Medical Device Inspections in the Postpandemic World: Are You Ready for New Approaches and Methods? – Webinar Recording/Transcript
$287.00
