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

Compliance Corner: On-Site Facility Inspections Are Back. Is Your Firm Adequately Staffed?

Executive Summary

King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.

You may also be interested in...



‘War Room’ Death Knell? Edwards Lifesciences Expert Predicts Inspectional Front, Back Rooms Will Be Pandemic Victim

Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.

The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection.

FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool

The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.

Topics

UsernamePublicRestriction

Register

MT144559

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