MDR & QMS training | next date: TBD
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.
Register your interest
Experts
Jean Blom – Quality Manager Medical Devices at Medace
Jean Blom is accountable for the daily quality assurance activities as Medace’s Quality Management Representative, and provides the strategy regarding medical device client planning, coordination, and execution.
He is the principal expert regarding quality requirements as defined by standards (ISO/IEC/EN), and their interactions with regulations such as the EU’s MDR (2017/745).
Before Medace, he worked hands-on in quality and regulatory for a start-up’s class IIA Active Diagnostic Medical Device, and as the quality systems-focused officer at a major multinational medical device developer and manufacturer in the ophthalmic surgery segment with a large variety of devices and operations; this provides him with a breadth and depth of experience that is both useful and familiar to Medace’s diverse client base.
Linda van Leeuwen – Regulatory Affairs Associate
Linda is responsible for supporting clients regarding the matters related to the regulatory compliance of their product and product development. This is achieved by advising, reviewing and teaching within client-focused projects, and by improvement and updates of the Medace QMS used for clients.
Linda has a BSc in biomedical research and has a vast amount of experience working for start-ups in the biomedical field. Before joining Medace she worked at one of the largest companies in ophthalmic surgery devices. There she was responsible for the regulatory side of product development and product changes, as well as regulatory intelligence, CE certification and 510(k) clearances, technical file maintenance of
ophthalmic surgery devices ranging from class I to class IIb, from reusable to sterile, from short-term use to implantable and active devices with software.
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Do you have a question about this training?
Contact Kurt Gielen
kurt.gielen@medacespace.com
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.
