"WA 0" - Enzyme

A Grateful Goodbye and a Confident Step Forward

July 23, 2025

Jacob and I started Enzyme in 2017 with a mission to empower life science companies to innovate better and faster. We set out to build the system we wished had existed during our time in engineering (myself) and quality (Jake)—addressing the exact gaps we once faced firsthand. I’m deeply proud of how over the past...

Medical Devices Pharma

Tariff Wars, Generic Drug Manufacturing Strain Already Stressed Global Medical Product Supply Chains – Can Companies Adapt?

February 14, 2025

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...

Medical Devices

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

September 26, 2024

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...

Medical Devices

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

September 12, 2023

As the number of medical devices that include software continues to grow, so too does the use of off-the-shelf (OTS) software in regulated medical devices. Defined as “a generally available software component used by a device manufacturer for which the manufacturer cannot claim complete software life cycle control (e.g., operating system, printer/display libraries),” OTS software has its own regulatory/quality considerations and deliverables when incorporated into a medical device.

SaMD

FDA Demands Greater Level of Software Documentation in New Guidance

June 28, 2023

Software as a medical device (SaMD) has evolved rapidly in the past 20 years, and the FDA has responded with a new final guidance for the content of premarket submissions for device software functions. This guidance calls for a substantially greater amount of documentation than was required by the 2005 version — an especially important point for companies that file infrequently with the FDA.

Medical Devices SaMD

Software Bill of Materials a Must-Have for Cybersecurity Management

May 3, 2023

While SBOMs may not fundamentally change your perspective on cybersecurity, they can be tremendously useful not just in managing cybersecurity across the total product life cycle (TPLC), but also in sustaining good relationships with customers and regulatory agencies.

Artificial Intelligence Digital Health Pharma

FDA Takes Next Step Toward Digital Health in Drug Development

April 5, 2023

The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.

SaMD

Opportunities for Smaller Software Developers Highlighted by MDCG

February 21, 2023

A new guidance from the Medical Device Coordination Group (MDCG) clarifies that software as a medical device (SaMD) product can operate under a limited amount of regulatory oversight when deployed only in a single healthcare entity, which gives smaller developers an opportunity to gain a foothold in the European Union (EU) while they add to their to-market capabilities.

Medical Devices

FDA Draft Guidance for Computer Software Assurance a Fresh Look at Risk

September 28, 2022

Thanks to an ongoing controversy over computer system validation (CSV) for non-device software, the FDA draft guidance for computer software assurance (CSA) might be one of the most widely anticipated drafts to come out of the agency in several years. The key point is that the FDA explicitly acknowledges that software used in production and compliance systems does not necessarily present a high degree of risk, a key concession for those who believe the standing approach to compliance is often a case of regulatory overkill.

Medical Devices

MDCG Warning Letter to Industry: No More MDR Delays

August 22, 2022

The European Union has undertaken several measures to address the difficulty of implementing the Medical Device Regulation (MDR), but these grace periods are coming to an end. The EU’s Medical Device Coordination Group (MDCG) recently advised medical device manufacturers that time is running out to reapply for a CE mark for existing devices in a position paper that serves as a warning that stragglers may be left out in the transition.‍

Older Posts

WA 0

A Grateful Goodbye and a Confident Step Forward

Tariff Wars, Generic Drug Manufacturing Strain Already Stressed Global Medical Product Supply Chains – Can Companies Adapt?

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

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

FDA Demands Greater Level of Software Documentation in New Guidance

Software Bill of Materials a Must-Have for Cybersecurity Management

FDA Takes Next Step Toward Digital Health in Drug Development

Opportunities for Smaller Software Developers Highlighted by MDCG

FDA Draft Guidance for Computer Software Assurance a Fresh Look at Risk

MDCG Warning Letter to Industry: No More MDR Delays

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