As a medical device manufacturer, you understand the importance of meticulous documentation. This documentation exhibits effective evidence that the critical aspects of your medical devices – including design, manufacturing, and quality control processes – are validated. By maintaining comprehensive documentation, you can demonstrate that your devices meet your specifications, customer specifications, and stringent regulatory requirements, […]
Ensuring that medical devices are manufactured to precise quality specifications is key for medical device manufacturers. Keeping this thought at the forefront of regulatory compliance issues underscores the importance of constantly fine-tuning manufacturing processes with patient safety in mind. Performance Validation (PV) has successfully worked with a global Medical Device Manufacturer based in Kalamazoo, Michigan […]
A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced. This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]
As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards. Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Excerpt from List […]
Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.
Skip to main content
