Category

Medical Devices

The latest posts about #Medical Devices

FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development
Sep 13, 2022
10
min read
FDA Remote Regulatory Assessments Draft Draws a Fine Regulatory Line
Aug 30, 2022
10
min read
Terms and Definitions Drive Concerns Over FDA’s Quality Systems Proposal
Aug 22, 2022
5
min read
FDA Guidance on EMC Signals a Shift in Compliance Requirements
Aug 12, 2022
5
min read
MDCG Warning Letter to Industry: No More MDR Delays
Aug 3, 2022
5
min read
Regulatory Framework Comparison Series: The Predicate Device
Jul 12, 2022
5
min read
Regulatory Framework Comparison Series: Software as a Medical Device
Jun 21, 2022
10
min read
Regulatory Framework Comparison Series: Device Cybersecurity
May 25, 2022
5
min read
EU and FDA Policies in Conflict over Product Designation
May 10, 2022
10
min read
FDA’s Refuse-to-Accept Guidance a Vital Piece of the Regulatory Puzzle
May 3, 2022
5
min read
FDA’s Cybersecurity Premarket Draft a Significant Rewrite
Apr 12, 2022
10
min read
FDA Guidance Offers Short Window for Appeals
Mar 22, 2022
5
min read
Harmonization by Reference the Driver of FDA’s Rewrite of Part 820
Mar 2, 2022
5
min read
Non-device Functions a Potential Hazard for FDA-regulated Products
Feb 8, 2022
10
min read
The Genus Dilemma: Cross-Referencing FDA’s GMP Requirements
Feb 2, 2022
5
min read
De Novo Final Rule Retains Pre-Decision Inspections
Jan 27, 2022
2
min read
Class I Devices Not Exempt From FDA Intended Use Rule
Dec 14, 2021
5
min read
FDA Predicts More Requests for Additional Information for Software
Dec 7, 2021
5
min read
Clarity of Intended Use a Key Point in IVDR Device Classification
Nov 10, 2021
5
min read
Moderate-Risk Designations Dominate FDA List of AI Devices
Oct 26, 2021
5
min read
The Risks of Different Risk Classification Systems
Oct 20, 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
FDA Cybersecurity Communications Likely to be Costly
Feb 19, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Feb 12, 2021
5
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
Breakthrough Devices May Draw Four Years of Medicare Coverage
Sep 22, 2020
9
min read
SubtleMR Demonstrates How AI Can Fit into the 510(k) Program
Aug 11, 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
Management System Status for ISO 13485 Complicates FDA Adoption
Jun 18, 2020
9
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
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
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read
Creating A Culture Of Quality
Feb 19, 2019
3
min read

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