Medical Device Single Audit Program (MDSAP) for Manufacturers
Identify the keys and tools required for a successful MDSAP audit
2-day training session (split over 5 half-days) | Virtual Classroom
Identify the keys and tools required for a successful MDSAP audit
2-day training session (split over 5 half-days) | Virtual Classroom
MDSAP should be considered as a strategic asset for organizations based globally, if they export or intend to export medical devices to participating countries.
The program allows an MDSAP auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
The program is beyond the pilot program and is now running full speed starting up to replace the normal structure audit.
The countries which are using the MDSAP reports and certificates are Australia, Brazil, Canada, Japan, and the USA.
Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and Republic of Korea’s Ministry of Food and Drug Safety are now Affiliate Members and World Health Organization and European Union are Official Observers to the MDSAP Program.
REQUIRED LEVEL
The requirements are based on ISO 13485, so a basic understanding and knowledge of the standard are beneficial.
Trainers
Pascal Bisson holds a Master of Business Administration from the University of Alberta, Canada, and a degree in Mechanical Engineering from Ecole Nationale d’Ingénieurs de Metz, France.
With more than 20 years of experience, he has been involved in leading projects in design and development, production, supply chain management and business development. His technical expertise spans various fields, including electromechanical devices, circuit boards, software/firmware, nanotechnology processes, molding, machining, and 3-D printing. Pascal has worked with organizations of all sizes, ranging from start-ups to large corporations, across different countries, such as EU, Canada, United States of America, and Mexico. He is also a co-author of several patents.
We offer a variety of training courses and we focus on your challenges and provide our attendees with a clear “take-home” value.