Manufactures 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 a Medical Device Establishment License. The BRC offers a full range of quality management training and consulting services for medical device manufacturers, suppliers and distributors, including:
- Quality Management Systems (ISO 13485, etc.)
- Lean Manufacturing and Process Improvement
- Risk Management (ISO 14971, FMEA, etc.)
- Corrective Action & Continual Improvement
- Review & Revision of Documentation
Public, on-site and online courses are offered across North America. Our training topics cover Quality Management Systems (ISO 13485, ISO 9001, etc.), Risk Management, Problem Solving & Continual Improvement, Process Improvement and more.
Auditing & Consulting
The BRC offers the medical device industry a full range of auditing & consulting services designed to help organizations improve processes, people, and performance.
Auditing services include assistance with, or full outsourcing of: Internal Audits, Gap Analysis & Pre-Assessment Audits, Supplier Audits, and Desk Audits to review documentation.
Our consulting services are focused on partnering with you to understand your business and tailoring our assistance to meet your needs. Our team of medical device specialists uses The BRC’s course materials, quality tools and resources to train, implement, facilitate…and empower your team with the skills and knowledge you need to be successful.
Implementation & Systems Management
The BRC’s quality specialists are fluent in the ISO, Quality and Management Systems that are required to comply with Health Canada regulations and to obtain a Medical Device Establishment License.
We work with companies to implement new Quality Management Systems, either as a full implementation partner or as a subject matter expert at key steps in the process.
The BRC also partners with organizations to provide advice and guidance, oversee major activities, and do the “heavy lifting” to ensure that your management system is functioning, improving and returning real value to your business.