New Australian Medical Device Regulations for Software and Personalised Medical Devices – Schedule 2 and 3
Medical Device Expert News
FDA issues a Final Rule to Require Medical Device Submissions in Electronic Format
EU – April 2019 update of the MDR and IVDR implementing measures rolling plan
EN ISO 14971:2019 was published today. For those wondering, both the ISO and EN versions were going to be published today, but ISO published the…
IVD companion diagnostics – Guidance on proposed regulatory requirements
Interesting discussion and what I usually see in medical device risk management, unfortunately – a bunch of pretty documents created to “pass the audit” but…
FDA Qualifies MRI Compatibility and Safety Software as a New Medical Device Development Tool
MDCG 2019-14 Explanatory note on MDR codes
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the…
ISO 14971:2019 was published yesterday – see here: https://www.iso.org/standard/72704.html