South San Francisco, California
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About Us

Enzyme’s mission is to automate and simplify life science regulatory approval and compliance. We reduce your cost of compliance and help bring your cutting-edge technology to market faster.

Our cloud based Quality Management System (QMS) streamlines documentation and integrates with tools you are already using. And our experts guide you through your entire regulatory and compliance lifecycle: from pre-submission, to product design and development, regulatory submission, and post-market compliance.

Enzyme supports all life science companies, with an emphasis on companies making digital health, or software as a medical device (SaMD), products.

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Twitter feed

DC Circuit Court strikes down FDA's ban of a device for a specific use, ruling that it amounts to regulating the practice of medicine, a power not granted to the Agency.
#FDA #CircuitCourt @RAPSorg @aami_connect

Tues 7/27, FDA hosts webinar to discuss 2 recent publications @EnzymeCorp featured in blogs - the Draft Guidance Remanufacturing of Medical Devices & the discussion paper for Strengthening Cybersecurity Practices w/ Servicing Medical Devices http://shorturl.at/oJLN0

Draft VALID Act expands FDA authority over IVCTs modified by users, and its phase-in could be < 3 years.

#FDA @RAPSorg @aami_connect #IVDD


WHO raises several key principles to consider in the evolving regulatory landscape of AI medical devices.

@WHO @FDAcdrhIndustry #artificialintelligence #medicaldevice #machinelearning @RAPSorg

Remanufacturers be warned - 21 CFR Part 820 is indeed a part of your life. If a party deliberately or inadvertently improves safety or performance - this may be deemed remanufacturing, including cumulative effects of multiple servicings. #medicaldevices https://www.enzyme.com/blog/fda-cites-record-keeping-inspections-in-remanufacturing-draft

FDA's multi-tiered medical device cybersecurity guidance landscape gets more complex as FDA releases new draft guidance on the servicing and remanufacturing of software in/as medical devices. https://www.enzyme.com/blog/fda-developing-cybersecurity-policy-for-serviced-devices

@RAPSorg @aami_connect #FDA #SaMD #cybersecurity #medicaldevice

New draft EC AI legislation is likely to increase regulatory burden for AI products in the EU.

@RAPSorg #artificialintelligence #machinelearning #SaMD @ASQ #cemarking #medicaldevice


FDA announces new draft guidance for Section 522 studies, shortening timelines and improving transparency.

@FDAcdrhIndustry @RAPSorg #postmarketsurveillance @ASQ


One of the difficult parts of risk management is that FDA’s provisions are scattered across several guidances. This blog post summarizes some of the provisions. https://www.enzyme.com/blog/fda-iso-and-the-risk-management-quandary #fda #riskmanagement #medicaldevices

FDA updates draft guidance on medical device products demonstrating electromagnetic compatibility (EMC). #fda #medicaldevices https://www.enzyme.com/blog/fda-electromagnetic-compatibility-requirements-growing

The IMDRF has released its five-year strategic plan for regulatory convergence which includes considerations for cybersecurity and AI, and a single premarket review process for medical devices. https://www.enzyme.com/blog/imdrfs-five-year-plan #AI #healthcare #cybersecurity

FDA’s Safer Technologies Program offers a quicker review process for products that significantly improve the patient risk-benefit profile. https://www.enzyme.com/blog/fda-step-program-offers-expedited-review #fda #digitalhealth

The EU’s Medical Device Coordination Group has updated its policy on remote audits during the COVID-19 pandemic. https://www.enzyme.com/blog/remote-audits-gaining-traction-in-the-era-of-covid-19 #COVID19 #DigitalHealth #COVID19

YC Bio founders often ask us when they should start thinking about the FDA. @reshmakhilnani and @seehafer outline basic rules for this complex question. https://blog.ycombinator.com/the-pre-product-startup-and-the-fda/

YC Bio founders often ask us about the FDA and the broader regulatory environment. @reshmakhilnani and @seehafer touch on some of the most important concepts bio founders should think about and distills them down to their essence.

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Where is Enzyme headquarters?

Enzyme headquarters is located at South San Francisco, California.

When was Enzyme founded?

Enzyme was founded in 2016.

How many employees does Enzyme have?

Enzyme has 30-39 employees.

What is Enzyme's core business?

Enzyme is Computer Software company.

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