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

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms
Artificial IntelligenceDigital HealthMedical DevicesRegulationOctober 31, 2024

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms

By Shawn M. Schmitt Communications Specialist, Enzyme The US Food and Drug Administration (FDA) has taken a critical step toward ensuring that makers of medical devices are all on the same page when it comes to defining terms related to artificial intelligence (AI) and digital health, says an ex-agency official. Posted online in late September,...

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MedTech Makers Can Get Devices to US Market Faster, Hasten Innovation By Drafting PCCP Change Plans, Industry Experts Say
Artificial IntelligenceMedical DevicesRegulationOctober 17, 2024

MedTech Makers Can Get Devices to US Market Faster, Hasten Innovation By Drafting PCCP Change Plans, Industry Experts Say

By Shawn M. Schmitt Communications Specialist, Enzyme A Predetermined Change Control Plan (PCCP) submitted to and approved by the US Food and Drug Administration (FDA) as part of the medical device review process can give some manufacturers a leg up by shaving months off of the time it can take for a product to come...

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Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech
Artificial IntelligenceMedical DevicesSaMDOctober 15, 2024

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

By Shawn M. Schmitt Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and...

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CDRH’s New Era: 6 Key Takeaways From the Shuren/Tarver Town Hall
Medical DevicesSeptember 26, 2024

CDRH’s New Era: 6 Key Takeaways From the Shuren/Tarver Town Hall

By Shawn M. Schmitt Communications Specialist, Enzyme For Jeff Shuren, parting ways with the US Food and Drug Administration is such sweet sorrow. He stepped down as the longtime Director of the FDA’s Center for Devices and Radiological Health this summer, paving the way for Michelle Tarver – CDRH’s Deputy Director for Transformation – to...

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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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