Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• European Authorized Representation
1/2-day course – 12th November and 10th December, Stockholm
Technical Documentation for medical devices
All medical devices sold in Europe must comply with relevant medical device regulations. The Technical Documentation is your proof of compliance. In this course, you will get to know more about how to avoid common mistakes and how to speed up the process of review and CE marking.
The course is intended for medtech professionals working within the field of QA/RA and product development. You will learn more about the requirements on technical documentation and what is expected from you as a manufacturer. After the course you will have the tools you need for managing a smooth third-party review and to avoid common mistakes.
From the programme:
- Why Technical Documentation?
- MDR Annex II
- MDR Annex III in short
- Common mistakes
- Recommendations of what needs to be checked before submitting to a Notified Body
Maria Eklycke, Quality and Regulatory Consultant at QAdvis.
You can read more about Maria here >>
12 November 2019
10 December 2019
09.00 – 14.00 (incl. lunch)
Sveavägen 63, Stockholm
The course is arranged in co-operation with Swedish Medtech. For more information go to Swedish Medtech.
Questions: email Pernilla Andrée or call +46-(0)8-586 246 17.