Medical Device Training … FOR BUSINESSES IN THE MEDICAL DEVICE INDUSTRY
Our training courses support businesses and their employees increase their knowledge on medical devices, plastic materials used in devices, medical device risk management and regulations and standards.
Courses can be customised to suit your business needs and schedule … from introductory through to development level, and run remotely or face-to-face.
MEDICAL DEVICE REGULATIONS
Increase your knowledge of the EU Medical Device Regulations and how it can be applied. To support you with the complexity of the new regulations, our Medical Device Regulations training course will help you understand how the regulations affect your organisation, what it means in practice, terminology, the structure of the regulations and their annexes, general safety and performance requirements and the technical documentation requirements.
The course also includes the impact of Brexit, post-market surveillance, risk management and supply chain requirements.
RISK MANAGEMENT OF MEDICAL DEVICES
In the medical device industry, risk management is a vital aspect of the lifecycle of your product. Risk management goes beyond product development and manufacturing. It’s a systematic process centred around product hazards when using the medical device … from concept and design through to decommissioning and disposal. An effective risk management process is an integral part of medical device design and manufacture.
Our risk management training course includes:
- Introduction to medical device risk management
- The EU MDR and MDD (UK MDR 2002)
- Risk analysis, risk evaluation and risk assessment
- Risk control and residual risk
- Overall residual risk and risk management review
- Production and post production activities
INTRODUCTION TO PLASTICS IN MEDICAL DEVICES
Medical devices range from simple devices such as syringes to highly sophisticated machines and equipment. Understand the use of plastics in medical devices, their properties, the material selection process, risk management, regulations and standards.
QUALITY MANAGEMENT FOR MEDICAL DEVICES
Quality management is the foundation for medical device manufacturers to maintain their regulatory compliance, achieve confidence in their products and drive improvements and effectiveness. This course includes what is quality management in the medical device industry and its importance, an introduction to ISO13485:2016, how to establish and maintain effective processes.
