Accelerating time to market with regulatory information management systems

ByDave Hadfield, Kalypso

16 Apr 21

Regulatory information management systems have existed for decades, but over time have matured significantly, especially in recent years

RegulationRegulatory Policy

MHRA urges people to continue getting vaccinated following Irish suspension of AstraZeneca jab

By Jamie Bell

15 Mar 21

The MHRA stated 'the evidence available does not suggest the vaccine is the cause' following reports of blood…

RegulationRegulatory Policy

FDA warns 25 companies to stop producing fake regulatory certificates for medical devices

By Jamie Bell

05 Mar 21

The FDA has written to 25 companies - including manufacturers, distributors and sellers - telling them not to…

RegulationRegulatory Policy

Adoption of ‘incredibly helpful’ AI and ML technologies set to surge following FDA action plan

By Jamie Bell

15 Feb 21

Last month, the FDA introduced a five-point action plan to help integrate AI- and ML-powered technologies into the…

RegulationRegulatory Policy

Leading medtech association ‘very concerned’ by EU export restriction on Covid-19 vaccines

By Jamie Bell

03 Feb 21

In the past week, the WHO, Canada and Japan have also criticised export restrictions introduced by the EU…

RegulationRegulatory Policy

Four recommendations for better digital health regulation driven by the pandemic

By Peter Littlejohns

22 Jan 21

MedTech Europe has recommended several of the changes made to digital health regulation in Europe during the pandemic…

RegulationRegulatory Policy

How have lockdowns and social distancing impacted the way medical device manufacturers are regulated?

By Jamie Bell

20 Jan 21

Jamie Bell speaks to the BSI's Gary Slack to find out how auditing and other means of medical…

RegulationCertifications

How could medical device regulation change under president-elect Biden?

By Peter Littlejohns

15 Jan 21

Global law firm Morgan Lewis released a set of predictions for medical device manufacturers explaining how a Biden…

RegulationRegulatory Policy

FDA launches AI action plan to harness ‘enormous potential’ in medical devices

By Jamie Bell

13 Jan 21

A new FDA action plan regarding AI involves further development of proposed regulatory frameworks and fostering a patient-centred…

RegulationRegulatory Policy

IVDR: What will these new EU regulations mean for in vitro diagnostics manufacturers?

By Jamie Bell

08 Jan 21

In 2022, the long-standing IVDD will be replaced by the IVDR, ushering in a new era regarding how…

RegulationApprovals