BSI issues first UKCA mark under new medical devices legislation

By NS Medical Staff Writer

29 Jan 21

Theatre instrument sets are the first to secure the new UK product marking

RegulationCertifications

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

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

Eight key medical devices given emergency use authorisation during Covid-19 pandemic

By Jamie Bell

02 Nov 20

Diagnostic tools, PPE products and patient monitoring systems are among the range of medical devices that have gained…

RegulationApprovals

MedTech Europe issues warning on counterfeit PPE products and fraudulent suppliers

By Jamie Bell

30 Oct 20

In a statement, MedTech Europe said selling counterfeit PPE products, and other fraudulent activities, jeopardise the safety of…

RegulationCertifications

Natural Cycles leverages popular wearable tech for contraception app

By Peter Littlejohns

22 Oct 20

Customers using the Natural Cycles contraception app will be able to use data from certain wearables to calculate…

ElectronicsRegulationCertifications

Velentium launches specialised cyber security training for medical device manufacturers

By Jamie Bell

06 Oct 20

The US engineering firm's cyber security programme will initially provide specialised training for medical device manufacturers via online…

RegulationCertifications

FDA announces plan to resume on-site inspections in the US this month

By Jamie Bell

16 Jul 20

The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe…

RegulationApprovals

Q&A: How Medidata eases the burden of device trials with its RTSM solution

By Jamie Bell

13 Jul 20

Medidata's vice president of product management Kevin Collier says its Rave RTSM solution for device trials boasts capabilities…

RegulationApprovals

Have US and UK medical device regulators done all they can to ease ventilator shortages caused by Covid-19?

By Jamie Bell

15 Apr 20

Experts on ventilator regulation in the US and UK weigh in on what relevant bodies have done to…

RegulationApprovals