This full-day MDR & QMS training is a deep dive into (new) MDR and QMS requirements according to EN ISO 13485:2016. This training will help you gain in-depth knowledge on key topics, supporting your current or future medical device development.
Target group
- Researchers who want to translate their medical innovation.
- Candidates who want to learn the improve core elements into their Medical Device Development.
- Candidates without any ISO experience who, professionally, will be directly involved in Medical Device development.
About the MDR & ISO 13485:2016
Medical device companies that intend to sell their products in the European market place must comply with the MDR legislation (EU 2017/745). This set of regulations came into effect as of May 2021 and replaced the Medical Device Directive (MDD). This change has introduced reclassification, new requirements and additional clinical & post-market activities for manufacturers of medical devices.
QMS requirements
The Medical Device Regulation also requires the manufacturer of medical devices and related services to establish an appropriate QMS for the design, manufacture, and use of the devices. The ISO 13485:2016 standard specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and relevant regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size.
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Experts
Gertjan Geelen – Quality Manager Medical Devices at Medace
Gertjan Geelen is responsible for planning and executing the daily quality assurance activities regarding Medace’s ISO 13485 certified QMS as well as the planning, strategy and coordination of the quality support activities for our medical device clients, serving as Management Representative. He ensures the compliance and staying up-to-date with international quality requirements as defined by the applicable ISO standards and MDR and IVDR regulations.
Jessica Gerards – Quality Manager GMP at Medace
Jessica Gerards is specialized in the area of Regenerative Medicine development, with the focus on ATMP. Jessica ensures compliance with international quality to accelerate the development of her clients’ products towards patients.
Erwin Waas – Regulatory and Quality Manager Medical Devices at Peercode
Erwin is regulatory affairs manager for Peercode’s medical device software. Additional roles are medical device consultant and quality manager. Erwin is part of Peercode’s Regulatory and Quality Team.
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Other training opportunities
Do you have a question about this training?
Contact Mark Huurneman
mark.huurneman@medacespace.com
T: +31 (0) 6 37 55 2018
About Medace
Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.
Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.
