Category

SaMD

The latest posts about #SaMD

Regulatory Framework Comparison Series: Software as a Medical Device
Jun 21, 2022
10
min read
FDA De Novo Device Program a Tremendous Value
Apr 26, 2022
10
min read
De Novo Final Rule Retains Pre-Decision Inspections
Jan 27, 2022
2
min read
FDA Developing Cybersecurity Policy for Serviced Devices
Jun 24, 2021
5
min read
CDRH Wraps Up Guidance for Nitinol Devices
Feb 12, 2021
5
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
IMDRF and FDA; Twin Stars in the Med Tech Regulatory Sky
Sep 9, 2020
8
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
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
Our top conference picks for SaMD companies
Jan 25, 2019
3
min read
FDA Pre-Cert v1.0 Explained: 2019 and the Promises of Years to Come
Jan 9, 2019
7
min read

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