Training Features

MDSAP: Medical Device Single Audit Program

This training will provide practical insights into the MDSAP framework, focusing on compliance with regulatory requirements from participating countries, including the US, Canada, Brazil, Japan, and Australia.
Format

Virtual Training

Level

Basic/Intermediate

Date

3 February 2026

Time

09:00 - 17:00 CET

Duration

8 hours

Trainer

René Schings

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Mastering MDSAP Compliance: Navigating the Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) is an international initiative that allows medical device manufacturers to undergo a single audit to meet the regulatory requirements of multiple countries, including the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and Australia (TGA). The goal of MDSAP is to streamline the audit process for manufacturers who market their devices in several countries, reduce duplication of efforts, and ensure global regulatory compliance. 

Led by René Schings, this training provides an in-depth understanding of the MDSAP requirements, the audit process, and how to prepare for a successful audit. It is designed for those involved in the regulatory affairs, quality management, and internal audit teams of medical device manufacturers who wish to implement or improve their MDSAP processes.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to streamline regulatory oversight and enhance global device safety through a unified audit approach. MDSAP enables recognized Auditing Organizations to perform a single audit that meets the requirements of multiple participating regulatory authorities, including those in the U.S., Canada, Brazil, Japan, and Australia. 

This training offers a comprehensive understanding of MDSAP requirements, audit structure, and best practices for preparation, equipping professionals in regulatory affairs, quality management, and internal auditing with the tools to ensure compliance and audit readiness.
Key Learning Objectives
  • Gain a comprehensive understanding of the MDSAP program and its benefits for medical device manufacturers.
  • Learn how to prepare effectively for an MDSAP audit, including internal audits and documentation requirements.
  • Understand the structure and stages of an MDSAP audit and the expectations from regulatory authorities.
  • Develop strategies for addressing audit findings, including implementing corrective and preventive actions (CAPA).
  • Learn how to harmonize your QMS to meet the requirements of multiple regulatory bodies under MDSAP.
  • Understand the role of post-audit activities and continuous improvement to ensure ongoing compliance.
  • Prepare for a successful MDSAP audit and ensure readiness for multi-country regulatory inspections.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one sessions, lasting 8 hours, providing a focused and efficient learning experience. The sessions will take place on 3 February 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 7 July 2026. Visit the registration page for more information.
Who Should Attend?
  • Regulatory Affairs professionals responsible for ensuring compliance with MDSAP requirements
  • Quality Management professionals overseeing QMS systems in compliance with MDSAP
  • Internal auditors preparing for or conducting MDSAP audits
  • Senior management involved in audit planning, execution, and CAPA implementation
  • Design and development teams responsible for meeting MDSAP compliance during product lifecycle
  • Manufacturing and operations staff involved in regulatory compliance and quality management systems
  • Professionals preparing for or involved in MDSAP certification and regulatory audits in the U.S., Canada, Brazil, Japan, and Australia.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Introduction to MDSAP
  • Understand the purpose and structure of the Medical Device Single Audit Program (MDSAP), including its participating regulatory authorities and the key benefits and compliance requirements for manufacturers.
  • MDSAP Audit Structure and Requirements
  • Gain an understanding of the MDSAP audit framework, including its core requirements for manufacturers and how it differs from individual regulatory audits such as those conducted by the FDA and Health Canada.
  • Preparing for MDSAP Audits
  • Develop the skills to effectively prepare for MDSAP audits by understanding the role of internal audits, creating a strategic audit preparation plan, managing documentation and audit trails, and ensuring team readiness and resource allocation.
  • The MDSAP Audit Process
  • Gain an understanding of the MDSAP audit process, including its key stages, on-site execution, auditor roles and responsibilities, and best practices for collecting and presenting audit evidence.
  • Audit Findings and Non-Conformities
  • Learn how to interpret MDSAP audit findings, implement effective corrective and preventive actions (CAPA), and ensure proper reporting and documentation to maintain compliance.
  • Managing Multi-Country Compliance
  • Gain an understanding of how MDSAP integrates regulatory requirements from the U.S., Canada, Brazil, Japan, and Australia, and learn strategies to harmonize quality management systems and address challenges in achieving multi-country compliance.
  • Post-Audit Activities and Continuous Improvement
  • Learn how to effectively follow up on MDSAP audit findings, implement corrective and preventive actions (CAPA), engage management in supporting remediation efforts, and drive continuous improvement post-audit.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating the Medical Device Single Audit Program (MDSAP), ensuring compliance with ISO 13485 and the regulatory requirements of participating countries.

Expert-Led Training for Practical Compliance

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
Write your awesome label here.