Training Features

ISO 13485: Internal Auditing with MDSAP Compliance

Gain practical skills to conduct ISO 13485 internal audits with MDSAP compliance and ensure your QMS meets global regulatory requirements.
Format

Virtual Training

Level

Basic

Date

7 and 17 April 2026

Time

14:00 - 18:00

Duration

2 x 4 hours

Trainer

René Schings

Certificate

Certificate included

Price

€ 1195 or equivalent currency

ISO 13485: Internal Auditing with MDSAP Compliance

Internal auditing is a key component of maintaining a compliant Quality Management System (QMS) under ISO 13485:2016. Regular and effective internal audits help ensure that an organization’s QMS is working as intended, meeting regulatory requirements, and continuously improving. When it comes to the Medical Device Single Audit Program (MDSAP), it integrates multiple regulatory requirements into one audit, streamlining the process for manufacturers selling medical devices in multiple countries, including the U.S., Canada, Brazil, Japan, and Australia. 

Led by René Schings, this interactive training provides the necessary skills to conduct internal audits effectively under ISO 13485, focusing on MDSAP compliance. It covers the structure of both ISO 13485 and MDSAP, the audit process, and best practices for conducting audits that meet the requirements of multiple regulatory authorities. After completing the training, participants will receive a certificate confirming their ability to carry out ISO 13485 internal audits with MDSAP compliance.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Effective internal auditing is essential for ensuring that a Quality Management System (QMS) under ISO 13485:2016 operates efficiently, remains compliant, and continuously improves. The Medical Device Single Audit Program (MDSAP) simplifies compliance for manufacturers selling devices in multiple countries, including the U.S., Canada, Brazil, Japan, and Australia, by combining regulatory requirements into a single audit process.

This hands-on training, led by René Schings, guides participants through the full internal auditing process under ISO 13485, with a focus on meeting MDSAP requirements. Attendees will learn how to plan and execute audits, report non-conformances, implement corrective actions, and apply best practices for audits that satisfy several regulatory authorities simultaneously. Upon completion, participants will receive a certificate demonstrating their ability to perform ISO 13485 internal audits aligned with MDSAP compliance.
Key Learning Objectives
  • Understand the requirements of ISO 13485:2016 and MDSAP, and their implications for internal auditing. 
  • Learn how to plan, execute, and report on internal audits for ISO 13485 and MDSAP compliance.
  • Gain knowledge of the auditing process, including audit preparation, documentation, and evidence gathering. 
  • Understand the specific MDSAP audit requirements and how they differ from ISO 13485 audits. 
  • Learn how to report audit findings and manage non-conformances effectively. 
  • Understand the importance of follow-up actions and continuous improvement in response to audit findings. 
  • Prepare for regulatory inspections and audits by ensuring that internal audit findings are addressed. 
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 two sessions, lasting 8 hours in total, providing a focused and efficient learning experience. The sessions will take place on 7 and 17 April 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, an additonal training session will be held on 20 and 26 February, 24 and 30 July, and 6 and 16 October 2026.
Who Should Attend?
  • Internal auditors responsible for auditing ISO 13485:2016 compliance and MDSAP regulations 
  • Quality Assurance (QA) and Quality Management professionals 
  • Regulatory Affairs professionals involved in ensuring MDSAP compliance 
  • Senior management responsible for overseeing QMS audits and corrective actions 
  • Employees involved in process or system audits and continuous improvement activities 
  • Professionals preparing for MDSAP certification or inspections 
  • Any staff involved in maintaining or improving the quality management system for medical device manufacturers.
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
  • Overview of ISO 13485 and MDSAP: Introduction to ISO 13485:2016 and MDSAP, key requirements and scope, and regulatory authorities involved (FDA, Health Canada, ANVISA, PMDA, TGA).
  • Internal Auditing Principles: Purpose and benefits of internal audits, types of audits (process, system, compliance), and the role of internal auditors in ensuring QMS effectiveness.
  • ISO 13485 Internal Auditing Process: Planning and conducting audits, developing audit plans, scope, and schedule, preparing checklists and criteria, and gathering evidence through interviews.
  • MDSAP-Specific Requirements for Auditing: Overview of MDSAP audit requirements, differences from ISO 13485 audits, understanding MDSAP audit reports, and auditing for multi-country regulatory compliance.
  • Audit Reporting and Non-Conformances: Reporting findings and non-conformances, writing actionable audit reports, communicating results to management, and implementing CAPA for audit findings. 
  • Follow-Up and Continuous Improvement: Importance of follow-up actions, timely resolution of non-conformances, and using audit findings for continuous QMS improvement. 
  • Preparing for Regulatory Inspections and Audits: How internal audits support inspections, best practices for ISO 13485 and MDSAP audits, and handling findings to ensure compliance during inspections. 

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 x.

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.
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