MDSAP Certification and TrainingJanuary 10, 2018 REDWIRE is news you can use from leading suppliers. Powered by FRASERS.
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Medical-device manufacturers can prepare for audits with BSI Group’s assistance
BSI Group is renowned for its skill and expertise in spurring businesses to reach their full potential. In addition, the company is a designated auditing organization, and one sector that it often works with is the medical-device industry.
For nearly a year, the Medical Device Single Audit Program (MDSAP) has been in effect all over the world, and at the beginning of 2019, Health Canada plans to end the country’s ongoing audit program and accept MDSAP certificates only. Fortunately, BSI Group is ready to help Canadian medical-device manufacturers comply with MDSAP requirements.
About the MDSAP
The MDSAP was first established in late 2014 in Australia, Brazil, Japan, and the United States as well as Canada. The new program aimed to develop a standardized international audit or inspection to ensure that makers of medical devices were satisfying regulatory requirements for their products, such as the QMS/GMP standards. BSI Group has been conducting MDSAP audits for more than three years now.
To help medical-device companies get up to date in terms with the new regulations and audit standards, BSI Group offers a new comprehensive two-day course. The Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course is recommended for quality-assurance and regulatory-affairs personnel with medical-device manufacturers that plan to expand their market reach to other MDSAP jurisdictions.
Areas covered by the MDSAP Fundamentals and Readiness Training Course include the following:
- Fundamentals of the MDSAP, including structure and scope;
- Differences between MDSAP and QMS audits;
- The ISO 13485 and 14971 standards;
- How to identify MDSAP-certified documentation;
- The seven auditing process requirements;
- Correct use of jurisdictional terminology;
- How to analyze data sources and control interactions; and
- How to prepare for a successful MDSAP audit.
Attendees will learn to improve their regulatory auditing skills, adjust their competence for MDSAP auditors, and assess their own audit models, in order to maintain compliance with the current incarnation of ISO 13485.
The next MDSAP Fundamentals and Readiness Training Course is scheduled for February 5 to 6 in Toronto. The registration fee is $1,800.
For more information, contact BSI Group.