Risky Business: FDA Trots Out Risk-Based Framework For Validating Software For Quality Systems, Device Production
Risky Business: FDA Trots Out Risk-Based Framework For Validating Software For Quality Systems, Device Production
September 13, 2022
3
min read
New FDA Guidance Doc Lays Bare Process For Requesting EUAs For Monkeypox Diagnostics
New FDA Guidance Doc Lays Bare Process For Requesting EUAs For Monkeypox Diagnostics
September 8, 2022
2
min read
MDCG Urges Compliance To EU’s MDR/IVDR In 19-Point Action Plan
MDCG Urges Compliance To EU’s MDR/IVDR In 19-Point Action Plan
September 2, 2022
2
min read
U.K. MHRA Gives Device Makers More Time To Comply With New Reg Framework
U.K. MHRA Gives Device Makers More Time To Comply With New Reg Framework
August 21, 2022
2
min read
Guidance on IVDR Significant Changes
Guidance on IVDR Significant Changes
July 19, 2022
2
min read
EUDAMED Database – Progress Updates
EUDAMED Database – Progress Updates
June 24, 2022
2
min read
The FDA and Medical Device Cybersecurity
The FDA and Medical Device Cybersecurity
May 20, 2022
2
min read
Are Your Policy And Procedures In Place To Be Recall Ready?
Are Your Policy And Procedures In Place To Be Recall Ready?
May 2, 2022
2
min read
FDA’s Digital Health Center of Excellence: Recent Activities and Plan for the Future
FDA’s Digital Health Center of Excellence: Recent Activities and Plan for the Future
March 29, 2022
2
min read