Training Features

ISO 13485:2016:​ Quality Management System Requirements

Join us on 28 and 29 May 2026 for a virtual training to master ISO 13485:2016 and implement an effective Quality Management System for medical devices.
Format

Virtual Training

Level

Basic

Date

28 and 29 May 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

René Schings

Certificate

Certificate included

Price

€ 1195 or equivalent currency

ISO 13485:2016 Quality Management Systems for Medical Devices

ISO 13485:2016 is the international standard for Quality Management Systems (QMS) specific to medical device manufacturers. It provides a comprehensive framework for ensuring the consistent design, development, production, and post-market surveillance of medical devices, ensuring compliance with regulatory requirements. As such it is a harmonized or recognized standard in many countries or jurisdictions. A robust QMS not only ensures product quality but also minimizes risks and enhances operational efficiency. 

Led by René Schings, this interactive training helps medical device manufacturers, subcontractors and suppliers understand the requirements of ISO 13485:2016 and its practical implementation. This training provides in-depth insights into the creation, maintenance, and auditing of a QMS that meets the standard’s requirements while supporting regulatory compliance. Upon completion, participants will receive a certificate confirming their understanding of ISO 13485:2016 and QMS implementation.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
ISO 13485:2016 sets the international benchmark for Quality Management Systems (QMS) in the medical device industry, providing a framework to ensure consistent design, development, production, and post-market surveillance while meeting regulatory requirements. A well-implemented QMS enhances product quality, reduces risks, and improves operational efficiency.

This virtual training is designed for medical device manufacturers, subcontractors, and suppliers, offering practical guidance on understanding and implementing ISO 13485:2016. Participants will gain in-depth knowledge on creating, maintaining, and auditing a compliant QMS and will receive a certificate upon completion confirming their expertise in ISO 13485:2016 and QMS implementation.
Key Learning Objectives
  • Understand the requirements and structure of ISO 13485:2016 for medical devices
  • Learn how to develop and implement a Quality Management System (QMS)
  • Understand the integration of risk management (ISO 14971) into the QMS
  • Understand how to effectively control production and service activities
  • Gain knowledge on managing design and development controls
  • Learn best practices for supplier management and outsourcing controls
  • Understand the role of post-market surveillance and CAPA in QMS compliance
  • Learn how to conduct internal audits and management reviews to maintain the effectiveness of the QMS.
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 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 28 and 29 May 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 11 and 12 March, 10 and 11 August, and 10 and 11 November 2026. More information can be found on the registration pages.
Who Should Attend?
  • Quality Management professionals and managers
  • Regulatory Affairs and Compliance professionals
  • Medical device manufacturers seeking ISO 13485:2016 certification or compliance 
  • Subcontractors and suppliers to the medical device industry requiring ISO 13485:2016 certification
  • Design and Development teams involved in QMS processes
  • Production and service staff
  • Supply Chain and Procurement teams managing supplier quality
  • Post-Market Surveillance (PMS) and CAPA professionals
  • Auditors and professionals responsible for internal audits and inspections.
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 ISO 13485:2016, including an overview of requirements and the importance of a QMS for manufacturers, subcontractors, and suppliers.
  • Quality Management System (QMS) structure, covering key clauses, documented procedures, records, and the establishment of a Quality Manual.
  • Risk management and risk-based approach, integrating ISO 14971, managing risks across the product lifecycle, and ensuring traceability of risk assessment.
  • Design and development control, including management of design processes, documenting reviews, verifications, validations, and managing design changes.
  • Supplier and outsourcing control, covering selection, evaluation, agreements, performance monitoring, and traceability of purchased products, services, and materials.
  • Product realization and production controls, including production processes, process validation, equipment calibration, and monitoring and measurement systems.
  • Post-market surveillance and corrective and preventive actions (CAPA), covering monitoring product performance, managing non-conformances, and implementing preventive measures.
  • Internal audits and management reviews, including conducting audits, analyzing findings for continuous improvement, and preparing for regulatory 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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