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Enzyme Blog

Automating life science regulatory and compliance

Check out our latest blog posts

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

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