MDEL Attestation Procedures

When applying for or renewing a Medical Device Establishment License, a Senior Official of the Company is required to make attestations regarding the availability of the required procedures.

What many Senior Officials do not realize is that by signing the attestations, they are also attesting to the adequacy of the procedures. If during a Health Canada Inspection, a Medical Device Inspector finds a procedure to not meet regulatory requirements, the Inspector will cite the Senior Official for making a false attestation.

DSA offers a full range of procedures to help your firm ensure that the required procedures are available to support compliance with the MDEL attestations.

We have stock Standard Operating Procedure (SOP) templates that have evolved over more than 20 years of dealings with Health Canada and managing compliance issues on behalf of our clients. Our SOPs have been subject to numerous audits by Health Canada Inspectors and have been written to meet the highest level of auditor scrutiny. DSA specializes in preparing SOPs that are succinct, effective and easy to follow. We offer a wide range of SOPs and Protocols to cover a full range of compliance topics.

For clients with existing SOPs, DSA can work with your team to review your SOPs against regulatory requirements and prepare a gap analysis to outline any shortcomings.

Contact us, for more details on how we can review or prepare your firm’s procedures to help ensure compliance with the MDEL attestations.