Design History File Remediation for Medical Devices

A Design History File (DHF) is a compilation of documentation that describes the design history of a finished medical device. The Design History File encompasses the objective evidence that the design has been developed in accordance with the Design and Development Plan, in compliance with regulatory requirements and design control requirements.

DHF for Medical Devices is a regulatory trending activity which ensures Manufacturers are up to date and aligned for stringent compliance's of Design Controls. This paper includes the details of all Design History File modules and important components or sections under each module related to 21.CFR820 and ISO 13485.

Download the Whitepaper

I acknowledge that I am not a U.S. Federal Government employee or agency, nor am I submitting information with respect to or on behalf of one.

Why are we asking you this?

HCL provides software and services to U.S. Federal Government customers through its partner ImmixGroup, Inc. Please contact ImmixGroup, Inc. at HCLFederal@immixgroup.com

I wish to be contacted by a HCL representative over phone*

Yes

Request a meeting

Preferred Communication Mode

Phone

Yes, I’d like HCL to provide my contact information to Cisco and NetApp so they can share the latest news and offers with me by email, post, or telephone. You may unsubscribe from receiving news and offers from Cisco and NetApp at any time by following the instruction in the communication received. Cisco and NetApp handle your information as described in Cisco privacy Statement and NetApp privacy policy respectively

Would you like to receive case studies, whitepapers, newsletters, announcements, and other relevant updates about products and services, events and webinars from HCLTech?

Yes

I have read HCLTech’s Privacy Policy and agree to the terms and conditions*

Select Preferences *

Case Studies

Whitepapers

Announcements

Events

Webinars