Artificial intelligence is transforming the medical device industry, enabling faster diagnoses, more personalised treatments and smarter connected healthcare. Discover how AI is being used in modern medical devices, the technologies driving innovation and the future of intelligent healthcare.
Don’t confuse QA and QC in your QMS. Discover the critical differences between Quality Assurance and Quality Control under ISO 13485, and learn how balancing both protects your device and your next audit.
Quality Assurance vs. Quality Control in Medical Devices Read More »
The shift from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR EU 2017/746) represents a fundamental overhaul of how technical files are structured. Under the legacy Directive, manufacturers relied on an Essential Requirements Checklist to demonstrate safety and performance. Under the IVDR, this has been completely replaced by the General Safety and Performance Requirements (GSPRs) found in Annex I.
If you are updating a legacy device technical file or migrating a quality management system, you cannot simply copy and paste your old compliance arguments. The GSPRs require a much higher degree of clinical evidence, lifecycle risk tracking, and technical specificity.
IVD Essential Requirements Checklist: Transitioning to IVDR GSPRs Read More »
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