ISO 13485 quality management systems for medical devices and IVDs provides the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed to harmonise their quality regulations under the Medical Device Single Audit Programme (MDSAP).
This training course will look to provide you with the processes to ensure you implement and comply with ISO 13485. Applicable for both device and diagnostic professionals, you will learn the concepts needed to understand, develop and implement a quality management system (QMS). You will also gain an overview of the MDSAP and how to prepare your quality system for MDSAP compliance.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.
What is included in a live online course?
- Direct access to an expert trainer
- Interactive and engaging sessions with exercises and discussions
- Bitesize learning
- Access to the Educo Life Sciences Training Portal
- Unlimited access to the recordings for 4 weeks after the last session
- Full access to the Educo Post Learning Implementation Plan (PLIP)
- A validated certificate of attendance available for you to download and file