Enzyme Team

My latest blog posts

New VALID Act Phase-in May be as Short as Three Years
Jul 23, 2021
4
min read
WHO Enters AI Debate with Report on Guiding Principles
Jul 16, 2021
4
min read
FDA Cites Record-keeping, Inspections in Remanufacturing Draft
Jul 1, 2021
5
min read
FDA Developing Cybersecurity Policy for Serviced Devices
Jun 24, 2021
5
min read
EU Draft Legislation for AI May Add Regulatory Hurdles
Jun 18, 2021
10
min read
FDA Tightens Turn-Around Times for Section 522 Studies
Jun 10, 2021
4
min read
FDA Reins in Timelines for Post-Approval Studies
Jun 10, 2021
3
min read
Fate of MCIT Uncertain, But Cures 2.0 a Possible Solution
May 24, 2021
10
min read
ML Algorithm for COVID-19 Incurs Large Premarket, Postmarket Studies
May 6, 2021
7
min read
FDA Calls for Evaluation of Tests for SARS Variants
May 3, 2021
10
min read
FDA, ISO and the Risk Management Quandary
Apr 27, 2021
10
min read
FDA Electromagnetic Compatibility Requirements Growing
Apr 20, 2021
10
min read
IMDRF’s Five-Year Plan Includes Single Review
Apr 6, 2021
10
min read
FDA STeP Program Offers Expedited Review
Mar 30, 2021
5
min read
Remote Audits are Gaining Traction in the Era of COVID-19
Mar 16, 2021
10
min read
FDA Action Plan for AI an Incremental Step
Mar 9, 2021
5
min read
FDA Cybersecurity Communications Likely to be Costly
Feb 19, 2021
10
min read
FDA Posts Microneedling Final Guidance
Feb 16, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Feb 12, 2021
5
min read
CDRH Guidance Agenda for FY 2021 Includes CDS Final Guidance
Feb 10, 2021
10
min read
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
Enzyme Offers Support for Teams Dealing with COVID-19
Mar 19, 2020
5
min read

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