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...
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...
By Shawn M. Schmitt Communications Specialist, Enzyme The tariff wars underway between the US and an array of other countries is straining already-stressed supply chains for pharmaceuticals, medical devices, and other medical products, says an expert on global supply chain management. But there are things manufacturers can do to alleviate supply chain pain points caused...
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...
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...
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,...
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...
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...
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,...
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...
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
