In the highly regulated and competitive world of medical device manufacturing, getting your product to market swiftly and safely is paramount. This journey is fraught with complex regulatory requirements designed to ensure product safety and efficacy. At the heart of navigating this challenging landscape successfully is the process of validation – a critical step that […]
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In the highly regulated world of medical device manufacturing, the Production Part Approval Process (PPAP) stands as a critical pillar. Ensuring that component suppliers meet stringent quality standards, this process is indispensable for manufacturers who are committed to maintaining the highest levels of product reliability and patient safety. Given the intricate nature of medical devices […]
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Laboratory Information Management Systems (LIMS) are pivotal in managing data, improving efficiency, and ensuring compliance in pharmaceutical and medical device manufacturing. However, the process of LIMS validation can be daunting, given its technical and regulatory complexities. This step-by-step guide aims to demystify the process and provide clear guidance for manufacturers. Step 1: Understanding Regulatory Requirements […]
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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, […]
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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 […]
Read MoreA 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 […]
Read MoreAs 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 […]
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