CPDEquivalent to 8 hours
CERTIFICATESAll delegates will receive a certificate on completion.
The 1-day course explores the Articles and Annexes of the European Directive 93/42/EEC and the relevance of ISO 13485, the quality standard for the medical device industry. It examines the roles of regulatory bodies and the requirements placed on manufacturers of CE-marked medical devices.
The training uses interactive workshops and discussion groups to encourage teams to work together as they consider how to apply this knowledge within their organisation.
- general managers/business unit managers
- quality and regulatory professionals
- management representatives/
- internal and external auditors
- those seeking an understanding of the Directive
This course complements our range of training courses for designing, developing and marketing medical devices.
- expectations of the EU in applying risk analysis to medical devices
- scope of the European Directive 93/42/EEC, its 22 articles and 12 annexes
- roles of the bodies defined in the Directive, particularly the MHRA
- allowed paths to be able to use a Declaration of conformity and the CE mark
- essential requirements and the role of risk assessment
- incident reporting requirements and the role of post-production surveillance
- classification criteria and clinical evaluation requirements
- sources of information and further guidance
- apply the articles of the European Directive 93/42/EEC and follow the acceptable paths to enable the use of a Declaration of Conformity and the CE Mark
- apply risk evaluation and risk control principles which affect decision-making on the acceptability of risks in bringing a device to market
A Certificate of Completion will be awarded to delegates who attend the whole course.
Bywater offers a range of complementary courses around the requirements for design and development of medical devices for sale in the EU and US. These include:
- fundamentals and principles
- internal auditing
- risk analysis and FMEA
- usability engineering
We offer the Understanding the European Directive 93/42/EEC concerning Medical Devices training as a dedicated course. With only your organisation to consider, you can choose the venue and the date to suit your team. The course is available both as a face-to-face option in a location of your choice, or as a live online class in our Virtual Classroom.
Metropolitan Police Service|16th Nov, 2023
Sense Biodetection Ltd|13th Nov, 2023
Premier Partnership|10th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Animal and Plant Health Agency (APHA)|7th Nov, 2023
Animal and Plant Health Agency (APHA)|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
The Royal Mint|25th Oct, 2023
Private|24th Oct, 2023
DSTL|17th Oct, 2023
Swann-Morton Ltd|13th Oct, 2023
Mars|10th Oct, 2023