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North America’s Training Center

Medical Device Single Audit Program (MDSAP) for Manufacturers

2-day training session

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About the training

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.

AnneLeRouzo

Anne Le Rouzo Lead Auditor and Product Reviewer

Anne has over 30 years of experience in medical device quality systems and international regulatory affairs. At GMED North America, Anne is a qualified lead auditor for CE marking and quality management system certification according to ISO 13485 and MDSAP, and a qualified product reviewer with expertise focused on high-risk medical devices, mainly orthopedic, cardiovascular, and neurovascular devices.

Prior to joining GMED NA, Anne worked extensively in the orthopedic industry managing Regulatory Affairs and Quality Assurance, participating in the design and development processes for new articular implants as well as the validation of the production processes.

She earned a bachelor degree in biochemistry and microbiology completed by an engineering degree specialized in food industry.

Who Should Attend

  • Management Representatives
  • MDSAP Implementation Teams
  • Internal Auditors
  • Others who would like to learn the MDSAP auditing process for management systems based on ISO 13485 using MDSAP Audit Model

Learning Objectives

  • Acquire the knowledge and develop the skills required to be prepared to support an efficient and successful MDSAP audit within your organization
  • Understand how the MDSAP program works and how it is different from the ISO 13485 through its country-specific regulatory audit approach, the grading and handling of the nonconformities, and the handling of the audit report
  • Understand MDSAP Audit Model and Audit Trail
  • Help your organization to assess and adapt your QMS processes with the MDSAP requirements for the jurisdictions where your products are marketed, to be prepared to support an efficient and successful MDSAP by your selected Auditing Organization

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
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MDSAP Program
  • MDSAP fundamentals
  • Principles and approach of the program
  • Regulatory requirements covered by the program
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The 7 MDSAP Processes structure and audit tasks
  • Differences with the traditional ISO 13485 audit
  • Linkage between the processes and tasks
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Application for MDSAP audit
  • Initial certification audit (different phases) and audit cycle
  • Audit situation: audit plan (selection of the tasks, defining the audit scope), non-conformity grading, audit report
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Quizzes all along the training
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