fbpx
 
 
Schedule a Demo

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...

Share
READ MORE
FDA Still Silent Regarding New QMSR Inspection Regime
Medical DevicesAugust 28, 2024

FDA Still Silent Regarding New QMSR Inspection Regime

The FDA draft rule for regulation of lab-developed tests (LDTs) is no radical departure from the Agency’s traditional regulatory scheme, but it would force clinical labs to conduct a major overhaul of their regulatory operations. There is still a debate as to whether the Agency is fully legally authorized to regulate LDTs, but there are other considerations which suggest the FDA’s timeline for this draft rule is highly ambitious.

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 Their support team's expertise ensured a smooth migration of our historical documents and is always available to answer questions.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

Connect with us

Product

Company

Product

Company

Newsletter