Our tutorials on medical device regulatory compliance are now available and can be accessed for free by clicking this link. Startups and scale-ups with limited experience on medical device regulations can refer to these tutorials to develop an understanding of the concepts and apply them to their development and market process.
Given the complexity of the process of developing a medical device and bringing it to the market, having a strong understanding and foundation on the basics of medical device regulations can significantly help startups as they work to make their innovations available in the marketplace, saving both time and money.
1. Importance of Intended Purpose. Medical Device or not? – this tutorial focuses on the importance of determining if your innovation is classified as a medical device, and helps you then determine which regulations apply to your device.
2. Regulations – Why do they exist, and how does it impact me? – this focuses on the purpose of the medical device regulations, as well as their implications.
3. What are the responsibilities of a “legal manufacturer,” and how can the Quality Manage System support me? – this course outlines and explores the responsibilities of a “legal manufacturer” throughout the device life cycle.
4. Processes – part I. Design & Development Process – this course focuses on the transition from the research phase into the controlled development process and highlights the importance of clearly defining the purpose of the device during this transition period.
5. Medical Device Software, definitions, risk classification, and the development process – this explores the criteria in determining if the software is classified as a medical device.
6. Processes – part II. Quality Management System – this course focuses on the importance of having a sufficient and efficient quality management system.
7. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) – this tutorial outlines the importance, purpose, and scope of a PMS plan and PMCF.
An introductory course outlining the whole training series is also available.
Click here and you will find all the available tutorial on medical device regulatory compliance and feel free to contact us directly if you have any questions.
