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Enzyme Blog

Automating life science regulatory and compliance

Check out our latest blog posts

FDA Rolls Out ASCA Pilot Program and Guidance
Oct 29, 2020
12
min read
New FDA Intended Use Rule Provokes New Concerns
Oct 22, 2020
10
min read
FDA Opens Digital Health Center of Excellence
Oct 4, 2020
8
min read
FDA: Work Continues on PreCert Pilot
Sep 29, 2020
8
min read
Breakthrough Devices May Draw Four Years of Medicare Coverage
Sep 22, 2020
9
min read
IMDRF and FDA; Twin Stars in the Med Tech Regulatory Sky
Sep 9, 2020
8
min read
HHS: Rulemaking Required for FDA Regulation of LDTs
Sep 3, 2020
9
min read
FDA and Software Assurance: A Solution to the Validation Impasse
Aug 18, 2020
9
min read
SubtleMR Demonstrates How AI Can Fit into the 510(k) Program
Aug 11, 2020
8
min read
Innovation in SaMD Regulation: Video Games as Medical Devices
Aug 4, 2020
8
min read
FDA, IMDRF Chart Different Courses on Cybersecurity
Jul 28, 2020
7
min read
Combination Products Still a Challenge for FDA
Jul 20, 2020
8
min read
FDA Not Flying Solo in Artificial Intelligence Regulation
Jul 16, 2020
10
min read
Making MDSAP Work for You
Jul 1, 2020
9
min read
The Single Device Audit: Great Hopes Still Unfulfilled
Jun 24, 2020
8
min read
Management System Status for ISO 13485 Complicates FDA Adoption
Jun 18, 2020
9
min read
Suspended Animation; U.S. LDT Regulation Behind EU
Jun 12, 2020
9
min read
Leftovers: Top Five Unfinished FDA Draft Guidances from 2019
Jun 7, 2020
8
min read
ISO 13485 and Part 820: Delays and Opportunities
May 29, 2020
8
min read
Best Practices for Handling Customer Complaints Post-Market
Mar 23, 2020
5
min read
Enzyme Offers Support for Teams Dealing with COVID-19
Mar 19, 2020
5
min read
How the Medical Device Sector Can Support Innovation Methods for Developing Digital Health Products
Mar 16, 2020
7
min read
A Guide to Navigating FDA Device Risk Classifications for New Products
Feb 21, 2020
5
min read
What Digital Health companies can expect from the FDA in 2020
Oct 17, 2019
2
min read
Expert Interview: Clinical Trial Planning for Startups with Boulder Clinical Science
Oct 15, 2019
5
min read
2019 RAPS Regulatory Convergence #2019RAPS
Sep 19, 2019
1
min read
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read
Creating A Culture Of Quality
Feb 19, 2019
3
min read
Our top conference picks for SaMD companies
Jan 25, 2019
3
min read
FDA Pre-Cert v1.0 Explained: 2019 and the Promises of Years to Come
Jan 9, 2019
7
min read

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