Medical Devices
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The FDA’s New Guidance on Wireless Devices
Description: The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It’s purpose is to “establish a system to adequately identify devices through distribution and use.” It requires the development of... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: The U.S. FDA released a new guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”, on August 13, 2012. Its purpose is to address the growing use of wireless technology in medical devices in... -
Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
Medical Device Changes and the 510(k)
Description: There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design... -
Robust Corrective And Preventive Action (CAPA)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA’s current K-97-1... -
Robust Verification and Validation
Description: Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP...
