Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
April 5, 2023
2
min read
FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request
FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request
March 10, 2023
4
min read
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
March 9, 2023
3
min read
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
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