Integrated Quality Management System

MDSAP and Health Canada Compliance for Medical Devices

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.

QMS Requirements for Medical Device Companies in the USA

A document outlining the current good manufacturing practices (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. In addition to meeting the FDA requirements, manufacturers can seek quality management system certification to demonstrate their commitment to maintaining high standards. Integrating an integrated quality management system helps streamline processes, ensuring that quality control is maintained across every aspect of production. Furthermore, QMS ISO 9001 certification can be pursued to meet global quality standards, showcasing a dedication to continuous improvement and customer satisfaction.

MDSAP and USFDA Compliance for Medical Devices

FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. However, inspections conducted “for cause” or “compliance follow-up” by FDA will not be impacted by this program. Additionally, the MDSAP would not apply to any required pre-approval or post-approval inspections in support of Premarket Approval (PMA) applications. It is important for manufacturers to ensure their quality management systems meet the ISO 9001 quality management system requirements, as this standard is integral to the MDSAP audit process. Compliance with ISO certification quality management system standards and fulfilling the quality management systems requirements ensures that medical device manufacturers maintain high levels of quality and safety throughout the product lifecycle.

Selling Medical Devices in Europe? We Assist with 21 CFR 820, MDSAP, & ISO 9001 for the USA & 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 fulfill 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). Furthermore, we can guide you in meeting FDA QMS requirements for devices sold in the U.S. and ensure that your system aligns with MDR QMS requirements for the European market. If you’re also seeking broader certification, we can support you in obtaining ISO 9001 quality management system certification for your organization.

Upgrade and Integrate Your QMS with Maven’s ISO 9001 Experts

• 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.