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

US FDA Kills ISO Voluntary Audit Program As MDSAP Efforts Accelerate

This article was originally published in Clinica

Executive Summary

The US FDA has terminated its three-year-old ISO 13485 voluntary audit program, which gave medtech companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.

You may also be interested in...



Interview: Spain's Sanifit Set For Significant 2020

The Mallorca-based biotech is building a strong data package for SNF472 which the company believes will be an effective treatment for a number of calcification disorders in dialysis patients.

Sun Denied Over US Antitrust Challenge

India’s Sun Pharma has been denied leave to appeal against a US court decision rejecting the company’s bid for dismissal of a multi-district antitrust lawsuit.

Former Sandoz Executive Kellum Admits US Price-Fixing

Former Sandoz executive Hector Armando Kellum has admitted involvement in a US generic price-fixing conspiracy, the US Department of Justice has announced.

Topics

UsernamePublicRestriction

Register

MT103085

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