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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

‘Tiny Tentacles of Risk’: Under FDA’s New QMSR, MedTech Companies Must Embed Risk Management Into Their Culture
ManufacturingMedical DevicesRegulationMarch 4, 2025

‘Tiny Tentacles of Risk’: Under FDA’s New QMSR, MedTech Companies Must Embed Risk Management Into Their Culture

By Shawn M. Schmitt Communications Specialist, Enzyme When the US Food and Drug Administration (FDA) begins auditing MedTech companies under the new Quality Management System Regulation (QMSR) in 2026, the agency’s facility investigators will be looking for more than simply ticking off compliance checkboxes. They will expect companies to demonstrate a culture of quality, where...

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Joint FDA/MDIC Pilot For MedTech Companies With Spotty Compliance Histories Successful – But Its Future’s a Big Question Mark
ManufacturingMedical DevicesRegulationJanuary 15, 2025

Joint FDA/MDIC Pilot For MedTech Companies With Spotty Compliance Histories Successful – But Its Future’s a Big Question Mark

By Shawn M. Schmitt Communications Specialist, Enzyme When Becky Fitzgerald strolled onto the production floor of a MedTech company participating in a pilot program aimed at improving the maturity of the firm’s manufacturing organization, she was immediately concerned. The overall building was not well lit, machines used in manufacturing were dirty, and the floor was...

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FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing
Artificial IntelligenceManufacturingPharmaMarch 21, 2023

FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing

The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.

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Enzyme's eQMS transformed our quality management process. The user-friendly system and rapid document loading made the switch from paper seamless. Their support team's expertise ensured a smooth migration of our historical documents and is always available to answer questions. With Enzyme's eQMS, we're confident our quality system is well-organized and audit-ready.
Juan Hinojosa, Quality EngineerClearCam
Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day.
Diego Rey, Chief Scientific OfficerEndpoint Health
The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process. Their level of professionalism and service has been outstanding.
Enhao Gong, CEOSubtle Medical
The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier.
Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies

Electronic Quality Management System

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