Industry Expert Learning Series HRDF SBL Claimable
Overview of the Canadian Medical Device Regulations (CMDR)
DURATION : One (1) full day INTRODUCTION This course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly in the Canadian market. Personnel responsible for quality systems for medical device manufacturers will benefit from this overview course which compares the management systems of these foreign regulations with the requirements of the quality management system outlined in ISO 13485:2003. Students will gain knowledge of the requirements of the Canadian Medical Devices Regulations to provide leadership for their organizations when placing medical devices in foreign markets.
Participants will be led by an experienced tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience. Participants will lead through exercises and discussion points, including considerations in harmonizing these requirements and the Global Harmonization Task Force (GHTF) with respect to medical devices regulatory requirements.
COURSE OBJECTIVES / OUTLINE
Understand the Intent and Requirements of ISO 13485:2003
Gain an Overview of the Canadian Medical Devices Regulations (CMDR)
Recognize the Relationship between ISO 13485:2003 and the CMDRs
Understand the Differences between ISO 13485:2003 and the CMDRs
Summarize the Process to Achieve ISO 13485:2003 CMDCAS Registration
Decision makers on quality management system strategy at medical device manufacturing organizations
Quality personnel in organizations interested in entering foreign markets
Management team members of medical device manufacturers
Quality managers in the medical device industry
Internal and external auditors of medical device manufacturing firms
PRE-REQUISITE General awareness of ISO 13485:2003 and experience in a medical device manufacturing environment is recommended.
iNTERESTED TO FIND OUT MORE? For enquiries, please email to email@example.com. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347