Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

New EU Notified Body Looks To Fill Gaps: Will Ireland-Based Group Provide Pressure Relief?

Executive Summary

New to the EU notified body space, NSF Certification Ireland was among the first to apply for notified body designation under the new medtech regulations last November. The group hopes to help relieve the pressure that is expected to build up, in particular, due to the IVD Regulation, leader James Pink explains.

You may also be interested in...



Q&A: Ireland's Success In Attracting Medtech Companies

Medtech Insight talked to Rachel Shelly, the Head of Medical Technologies for IDA Ireland, about the Irish government's continuing efforts to attract medtech companies, the implications of Brexit, and the growing emphasis on data-analytics within the medtech industry in Ireland.

NSF's Trautman Dishes On Path To Becoming An AO For MDSAP, Offers Audit Advice

NSF International recently became one of only 14 auditing organizations authorized to conduct Medical Device Single Audit Program audits. Medtech Insight asked NSF's Kim Trautman about the AO process her firm went through, and MDSAP in general.

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT122432

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel