Start-up tutorials
A guide to regulatory compliance
Taking your medical device from idea to market can be a complex process which requires knowledge of medical device regulations. This introduction will make you aware what is needed to obtain a CE mark. The tutorials will guide you through the process; realising your ideas from research and development; to the essential requirements for CE-marking and to get market access.
If you are a start-up with little to no knowledge on medical device regulations and the CE-marking process, our guide is a quick way to understand the basics and apply them to your development process.
Medical Devices - From Idea to Market
Free on-demand tutorials for start-up companies
0. Content and purpose
An introduction to the training series and why it is so important to understand the regulatory processes when developing a medical device.
1. Importance of Intended Purpose. Medical Device, or not?
How do I know if my innovation is classified as a medical device, and why is it important? – Knowing which regulation that applies when placing a product on the market is crucial: incorrect assumptions may lead to unexpected costs and severe delays in time to market.
2. Regulations – Why do they exist, and how does it impact me?
What is the purpose of medical device regulations, and what is their impact for me, as a designer/inventor/owner of a start-up company? For a device to become CE-marked, the legal manufacturer must verify compliance to the regulations, in proportion to the risk. But how should this be done?
3. What are the responsibilities of a “legal manufacturer”, and how can the Quality Management System support me?
Which requirements apply to me, as a legal manufacturer, before and after the launch? How can the QMS help me demonstrate compliance? The legal manufacturer is responsible for product performance and safety, throughout the device life cycle, and must define suitable means of control, using the quality management system.
4. Processes – part I. Design & Development Process
How do I manage the transition from research into a controlled development process?
At the end of the research phase, resulting in a concept (or proposed solution) the product development process commences, and the design and development plan must be established. At this stage it is critical that the intended purpose of the device is clearly defined, to determine relevant design, verification, and validation activities.
5. Medical Device Software, definitions, risk classification, and the development process
Which criteria will determine whether the software I developed is considered a medical device, or not?
How is medical device software classified under MDR? Which standards and guidance documents do I need to take into consideration to ensure that my development process is aligned with the regulations?
6. Processes – part II. Quality Management System
Signing a “Declaration of Conformity – what does it mean? What is behind a successful CE-marking process?
At the end of your development phase the technical documentation must be complete and well organized to facilitate a Notified Body review and reduce the number of questions, but you also need to show that your quality management system is both sufficient and efficient.
7. Post-Market Surveillance (PMS) and PMCF
Why do I need a Post-Market Surveillance plan, when I submit my Tech.Doc.? What is the purpose and scope of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)?
The Benefit-Risk Analysis shall be kept up to date over the device life cycle. Thus, the manufacturer must establish methods to collect clinical data, confirm risk assessment, and capture any new or emerging risks.
