Medical Device Quality Training
Manufacturers of Class II, III and IV medical devices in Canada must establish and maintain a certified ISO 13485 Quality Management System in order to comply with Health Canada requirements and obtain and Medical Device Establishment License.
The BRC offers a full range of quality management training and related services for medical device manufacturers, suppliers and distributors…
ISO 13485:2016 QUALITY MANAGEMENT SYSTEMS
A full selection of training courses that address the specific requirements of the ISO 13485:2016 standard for medical device quality management systems, how they are implemented within the organization, and how to conduct internal audits of an ISO 13485:2016 QMS.
Includes courses appropriate for quality team members, internal auditors, and executive management.
MDSAP – Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is an international program through which a single audit of a medical device manufacturer that will be accepted by multiple regulators to address QMS/GMP requirements. Participating regulatory authorities include Australia, Brazil, Canada, Japan and the USA.
BRC courses cover MDSAP fundamentals, structure, scope, documents and audit sequence.
PROBLEM SOLVING & PROCESS IMPROVEMENT
One of the keys to success in a competitive industry is the ability to maintain and improve efficiency through effective problem solving and process improvement.
Available courses include Root Cause Analysis, 8D Problem Solving, Process Mapping, and more. Training can be classroom/theory only or can be based on practical workshops where cross-functional teams gain practical experience.
Efficient and effective audits are a cornerstone of Quality and Quality Management Systems. From internal audits to customer audits and more, your audit team needs the knowledge and skills required to support your organization’s goals and expectations.
These BRC courses are focused on generic auditor skills that can be applied to a variety of needs. For ISO 13485 auditor training see ISO 13485 training courses above.