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Enzyme Blog

Automating life science regulatory and compliance

Check out our latest blog posts

FDA Cybersecurity Communications Likely to be Costly
Enzyme Team
Feb 19, 2021
10
min read
FDA Posts Microneedling Final Guidance
Enzyme Team
Feb 16, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Enzyme Team
Feb 12, 2021
5
min read
CDRH Guidance Agenda for FY 2021 Includes CDS Final Guidance
Enzyme Team
Feb 10, 2021
10
min read
FDA Rolls Out ASCA Pilot Program and Guidance
Enzyme Team
Oct 29, 2020
12
min read
New FDA Intended Use Rule Provokes New Concerns
Enzyme Team
Oct 22, 2020
10
min read
FDA Opens Digital Health Center of Excellence
Enzyme Team
Oct 4, 2020
8
min read
FDA: Work Continues on PreCert Pilot
Enzyme Team
Sep 29, 2020
8
min read
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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