QA/RA Consulting, Auditing & Training
Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols You├óΓé¼Γäóre in the final stretch of your go-to-market plan and you├óΓé¼Γäóre ready to label your finished medical device. Labeling is the easy part, right? Not quite. When it comes to medical devices, the term├é┬álabeling├é┬áencompasses much more than a sticker ├óΓé¼ΓÇ£ it refers to […]
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Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols This is the first article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient├é┬áPDF. Part 1: This article Part 2:├é┬áNon-Product Software (NPS) Validation For Medical Device Manufacturers Part 3:├é┬áWriting NPS Protocols And Testing […]
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ISO 14971 and the Basics of Medical Device Risk Management Explained This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on├é┬árisk management planning. We’ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. From […]
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25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW Does this situation sound familiar?├é┬áYou├óΓé¼Γäóre sitting on an existing valid Medical Devices Directive (MDD) certificate that expires sometime before May 26, 2024. You assume that any obligations to meet the requirements under the Medical Device Regulation (MDR 2017/745) don├óΓé¼Γäót apply until you […]
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Pharma Process Validation: Where Do We Start? The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make sure that every process step performs as expected based on quality design, with the ultimate goal […]
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Drug, Device, or Both? Overview of FDA Premarket Regulation of Combination Products A vaccine in a prefilled syringe. A metered-dose inhaler. A nicotine patch. A drug-eluting stent. These are examples of so-called combination products that mix drug, device, and/or biologic. They are among the most closely scrutinized products by FDA, European, and other authorities. While […]
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