Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR
Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR
February 2, 2023
3
min read
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
January 13, 2023
4
min read
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
December 20, 2022
3
min read
Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
December 12, 2022
4
min read
Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
December 5, 2022
4
min read
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
November 29, 2022
2
min read
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
November 8, 2022
9
min read
International Group ICH Offers Detailed Protocol Template For Clinical Trials
International Group ICH Offers Detailed Protocol Template For Clinical Trials
November 7, 2022
2
min read
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
October 13, 2022
3
min read