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

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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Data Bias in AI/ML-Enabled MedTech Takes Center Stage in Forthcoming ISO TS 24971-2 Risk Management Doc
Artificial IntelligenceMedical DevicesDecember 19, 2024

Data Bias in AI/ML-Enabled MedTech Takes Center Stage in Forthcoming ISO TS 24971-2 Risk Management Doc

By Shawn M. Schmitt Communications Specialist, Enzyme Data bias in medical devices that are enabled with artificial intelligence (AI) and machine learning (ML) will play a front-and-center role in an upcoming Technical Specification (TS) document from the International Organization for Standardization (ISO). ISO TS 24971-2 will serve as a companion guide to ISO TR 24971:2020,...

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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 Their support team's expertise ensured a smooth migration of our historical documents and is always available to answer questions.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

Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise

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