Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

AUDITORS’ ORATORY: It’s all about communication as EU unannounced audits turn commercial relations into marriages

This article was originally published in Clinica

Executive Summary

The days when an intermittent update between medical device manufacturers and notified bodies in the EU was sufficient are over. In the new era of unannounced audits, it is more important now than ever for manufacturers to invest in a timely, pertinent and ongoing communication with their notified bodies. In this first instalment of Auditors Oratory, a new Clinica column that gives valuable insight into the workings of notified bodies, Chris Jepson* shares his experience at UK notified body SGS and explains why medtech industry needs to heed this advice to avoid additional expense, regulatory problems and - in extreme cases - loss of certification and ability to trade in the EU

Topics

UsernamePublicRestriction

Register

MT102330

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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