Category

Regulation

The latest posts about #Regulation

The Risks of Different Risk Classification Systems
Oct 20, 2021
10
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 STeP Program Offers Expedited Review
Mar 30, 2021
5
min read
FDA Action Plan for AI an Incremental Step
Mar 9, 2021
5
min read
FDA Posts Microneedling Final Guidance
Feb 16, 2021
10
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
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, IMDRF Chart Different Courses on Cybersecurity
Jul 28, 2020
7
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
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
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
2019 RAPS Regulatory Convergence #2019RAPS
Sep 19, 2019
1
min read
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read

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