AAMI News January 2018

Standards Spotlight: The Compliance Countdown Has Begun for 13485:2016

The clock is ticking for medical device manufacturers who supply products internationally to comply with the most recent version of ANSI/AAMI/ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes.

“Certificates to ISO 13485:2003 will cease to be valid in March 2019, and a Medical Device Single Audit Program (MDSAP) certificate based on ISO 13485:2016 will be required for access to the Canadian market after January 2019,” explained Eamonn Hoxey, an international consultant for quality and regulatory compliance matters.

The 2016 version of this quality management system (QMS) standard contains numerous clarifications and additions, according to Mark Swanson, principal consultant at H&M Consulting Group, LLC in Becker, MN. The changes, as noted by Swanson in an AAMIBlog post, include the following:

  • Requirements related to risk-based thinking within the medical device organization’s QMS and other areas in addition to product realization (e.g., complaint handling, corrective and preventive action, competency of personnel, and supplier controls).
  • A greater emphasis on the responsibilities of management to review information related to the suitability, adequacy, and effectiveness of the QMS and to assess opportunities for improvement.
  • Clarification that to “document” a procedure or process requires the organization to establish, implement, and maintain that process in addition to providing appropriate documentation.
  • Reinforcement of the importance of competency of personnel.
  • The need to validate software for its application, including QMS software, process control software, and software used in monitoring and measurement.
  • A greater emphasis on supplier controls.
  • The use of standards and regulatory requirements as an input to product design and development.
  • An additional focus on feedback with new requirements related to complaint handling and regulatory reporting.
  • The explicit requirement to take corrective action without undue delay.

AAMI Revamps Quality System Course to Meet Changing Needs

To help medical device manufacturers broaden their knowledge of QMS regulatory expectations, AAMI has updated its Quality System Requirements and Industry Practice course to include ISO 13485:2016 and the MDSAP, in addition to the Food and Drug Administration’s (FDA’s) Quality Service Regulation (QSR).

“Whether you are new to the industry or are an experienced professional, you will gain knowledge on establishing and maintaining a compliant and effective QMS for today’s global market,” said Jack Ward, AAMI lead faculty member and codeveloper of the course. “This updated course provides a comprehensive and current view of FDA, E.U., and MDSAP medical device QMS requirements.”

The content of the intensive 4.5-day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, FDA, industry consultants, and members of the committees responsible for the development of applicable standards, such as 13485 and ANSI/AAMI/ISO 14971, Medical devices—Application of risk management to medical devices.

With the knowledge gained from this course, professionals directly involved in meeting quality system requirements will be able to examine their QMS to determine if it complies with the QSR and 13485.

The newly redeveloped quality system course will be offered for the first time March 26, followed by additional dates throughout the year.

More information about The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements course can be found at AAMI University.

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