Introduction
Canada- QMS requirements for medical device companies
MDSAP and Health Canada
USA QMS requirements for medical device companies
MDSAP and USFDA
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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.
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.
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.
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.
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.