Best QMS Software for ISO 9001 and ISO 13485
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FDA and Software Assurance: A Solution to the Validation Impasse
August 18, 2020
The FDA’s approach to validation of computer systems used in device manufacturing IT systems hasn’t drawn the attention that software as a medical device has, but that doesn’t mean this requirement hasn't wanted for controversy.
Signs of Renewed Interests in FDA Third-Party Review Program
June 10, 2025
The FDA third-party review program for 510(k) devices, known as 3P510k, may be revived if recent signals from the agency and Capitol Hill are any indication. While we at Enzyme do not see the 3P510k program as a universally faster path to market for all 510(k) filings, recent developments suggest that this program could once...
FDA’s Loss in LDT Lawsuit Not the Last Word on Enforcement
April 29, 2025
The FDA’s loss in a district court lawsuit over the final rule for lab-developed tests (LDTs) was a watershed moment in the history of regulation of these tests, although the agency may yet appeal the decision. The outcome of the case, even if it stands, does not eliminate the FDA’s authority to indirectly oversee the...
‘Tiny Tentacles of Risk’: Under FDA’s New QMSR, MedTech Companies Must Embed Risk Management Into Their Culture
March 4, 2025
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...
Q&A: Discussing the Power of Real-World Data With Flatiron Health’s Craig Serra
January 23, 2025
By Shawn M. Schmitt Communications Specialist, Enzyme If there’s anyone who understands the power of companies using real-world evidence (RWE) and real-world data (RWD) to support clinical development, it’s Craig Serra. Three years ago, Serra’s daughter was a mere 3 years of age when she was diagnosed with cancer. Serra was working in Global Development...
Joint FDA/MDIC Pilot For MedTech Companies With Spotty Compliance Histories Successful – But Its Future’s a Big Question Mark
January 15, 2025
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...
Data Bias in AI/ML-Enabled MedTech Takes Center Stage in Forthcoming ISO TS 24971-2 Risk Management Doc
December 19, 2024
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,...
Ex-FDAer Says Real-World Data Just as Good as Clinical Data: ‘I Will Take This to the Grave’
December 4, 2024
By Shawn M. Schmitt Communications Specialist, Enzyme Call it “proving by doing”: A former Food and Drug Administration (FDA) official who led the effort to draft the US agency’s very first guidance document on real-world data says it’s imperative that pharmaceutical and medical device manufacturers shake off concerns about using RWD to support new product...
Embrace Real-World Evidence To Avoid Costly Prospective Randomized Trials That Can ‘Strangle Innovation,’ RWE Expert Says
November 15, 2024
By Shawn M. Schmitt Communications Specialist, Enzyme The widespread collection and use of real-world data (RWD) by pharmaceutical and MedTech manufacturers to support new product submissions is teetering on a tipping point in these industries, yet one expert and longtime RWD proponent says many companies are still gun-shy about presenting such data to a regulator’s...
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
