Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
October 12, 2022
7
min read
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
October 7, 2022
2
min read
Kiss Your CDs And Thumb Drives Goodbye: FDA Will Accept Only Electronic 510(k) Submissions Next Year
Kiss Your CDs And Thumb Drives Goodbye: FDA Will Accept Only Electronic 510(k) Submissions Next Year
September 23, 2022
2
min read
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
September 15, 2022
3
min read
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