New Guidance Released on EU MDR Vigilance Terms and Concepts
New Guidance Released on EU MDR Vigilance Terms and Concepts
March 2, 2023
5
min read
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
March 2, 2023
3
min read
US Reimbursement for Medical Device and IVDs – What Startups Should Know
US Reimbursement for Medical Device and IVDs – What Startups Should Know
February 10, 2023
3
min read
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
VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation
VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation
January 23, 2023
2
min read
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
January 18, 2023
5
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Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers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