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Integrated Quality Management System

ANSWERED ON THIS PAGE:

  • How will ISO 13485:2016 and the MDSAP integration affect QMS requirements?
  • Will ISO 13485 certification be able to meet QMS requirements in all countries?

The quality system conforming to ISO 13485 is expected to be insufficient in the USA and Canada. The US Food and Drug Administration needs 21 CFR 820 and, the Health Canada requires compliance to Medical Device Single Audit Program (MDSAP). These certifications require additional QMS and regulatory criteria before your device is approved for sale.

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Canada- QMS requirements for medical device companies

Under MDSAP, manufacturers of Class II, III, and IV medical devices must demonstrate ISO 13485 compliance. The QMS requirements of the Canadian Medical Devices Regulations (CMDR) are included in the MDSAP. Before your device can be sold in Canada, a Health Canada and MDSAP-accredited Auditing Organization (AO) must certify your MDSAP-compliant quality system. As of January 1, 2019, MDSAP compliance is mandatory.

MDSAP and Health Canada

As part of their Canadian Medical Device Conformity Assessment System (CMDCAS) accreditation programme, Health Canada will conduct an MDSAP audit. Upon the successful completion of the pilot, Health Canada intends to establish the Medical Device Single Audit Program as a means to achieve regulatory compliance for quality management system requirements in Canada.

USA QMS requirements for medical device companies

A document outlining the current good manufacturing practises (CGMP) requirements is the FDA 21 CFR Part 820, often known as the Quality System Regulation (QSR). This document oversees manufacturing processes to guarantee that their goods comply consistently with applicable specifications and regulations. The quality system approved by the FDA is FDA 21 CFR Part 820. These guidelines are designed to assure safe and effective medical devices. Medical device makers to ensure compliance with FDA 21 CFR 820 conduct FDA inspections.

MDSAP and USFDA

FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA will not be affected by this program. Moreover, the MDSAP would not apply to any necessary pre-approval or post-approval inspections in support of Premarket Approval (PMA) applications.

Are you already selling your medical device in Europe? We can assist with 21 CFR 820 and MDSAP compliance in the United States and Canada.

If you have already implemented ISO 13485 to sell in Europe and want to sell your device in the United States, Canada Brazil, Japan or Australia, we can assist you in upgrading your QMS to fulfil all country specific standards. We will expand on your current ISO 13485 quality system by adding particular procedures and paperwork required to comply with 21 CFR 820 and MDSAP. We can also assist you in ensuring that your ISO 13485 certification is issued by an MDSAP-accredited Auditing Organization (AO).

HAVE YOU DECIDED TO TAKE THE NEXT STEP FOR YOUR QMS UPGRADE AND INTEGRATION? LET THE EXPERTS AT MAVEN HANDLE IT:

  • MAVEN specializes in medical device regulatory compliance.
  • Our consultants have assisted medical device companies worldwide with ISO 13485 QMS integration with 21 CFR and MDSAP.
  • A MAVEN quality management system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.
  • In addition to ISO 13485 consulting, we can assist with medical device licenses and establishment licensing in various countries.

Countries included in MDSAP

TGA requires assessment of compliance of the medical device to the Medical Device authorisation requirements where the MDSAP audit report is used as an evidence. However, if the device is exempted this might not be required.

ANIVSA pre-market and post-market assessment procedures require the MDSAP audit reports to be utilised as an input for regulatory technical evaluation.

MDSAP audit outcomes aid in assessment of regulatory compliance for quality management systems in Canada.

MDSAP audit reports are accepted as alternative of FDA routine inspections where these are not applicable for pre-approval and post-approval inspections, Pre-market approval or PMA applications.

MDSAP reports are used as a trial to allow exemption from on-site inspection of the manufacturing site; To replace substantial part of documents required for the inspection with the MDSAP audit report by the Marketing Authorization Holder

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