This training provides guidance on implementing the requirements specified in the Medical Device Regulations (MDR) and focuses on motivating you to develop a clear project plan and how to integrate requirements into your business. Furthermore, you will gain the confidence and expertise to evaluate and implement your own requirements more specifically.

The MDR requires manufacturers to fulfill detailed requirements to bring medical devices to market in the European Union. MDR focuses on safety and performance of device, emphasizing market requirements, conformity assessment, aspects of quality control, market surveillance (PMS), transparency and traceability.

 This regulation will affect all medical device manufacturers, importers, distributors and representatives in the EU. Subcontractors/suppliers will also be affected, as well as manufacturers of certain non-medical devices (for example, devices used for cosmetic purposes or contact lenses used to change eye color without correcting vision).

 

Who should attend this training courses?

• Managers, heads of departments and related technical staff, quality staff, QA/QC

• Member of ISO system, QMS

• Individuals who want to become an specialist / expert in the Medical Device Regulation (MDR) for CE

 

Purpose of this training course:

• Implement requirements concerning the steps for Conformity Assessment

• Understand and meet the requirements in the Medical Device Regulation (MDR) for CE

• Attachment General introduction to the new MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

 

Duration: 1 day

Fee: 8.000.000 VNĐ/ participant

 

What are the benefits of the course?

• Get in-depth knowledge of medical device regulation (MDR) for CE

• Develop confidence to apply this knowledge in your organization

• Can perform project analysis and planning

• Know each specific requirements and regulations for effective implementation

 

What will the training include?

• Detailed course material

• Tea-break (Non tea-break for online training)

• Won-Med Certification Body Training Academy Certificate

 

Why choose training from Won-Med?

• Won-Med with a team of lecturers who are leading experts in your field, we train in-depth courses on ISO international management systems, CE/FDA certification, Lead Auditor. The courses are designed in a tailor-made style to suit each industry and each type of business. With a team of lecturers who are truly passionate about sharing their knowledge and making sure you can capture the most solid knowledge to apply to your own work.