Creating and Maintaining Technical Files and Design Dossiers
This one day course is designed to support manufacturers by confirming current regulatory requirements of technical documentation. The aim of the course is to allow you better manage the creation of technical files for the certification process for the European Union.
On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.
Who should attend?
- Regulatory, Design and Development Professionals
- Quality Managers
- Clinical Affairs Specialists
- Production Managers
What will I learn?
On completion of this training, participants will be able to:
- Confirm the technical documentation requirements as specified in the Directive
- Interpret the general requirements of the Directive using relevant and harmonized standards together with various European & GHTF guidance documents for specific products
- Define the process enabling the creation and maintenance of compliant technical files and design dossiers
- Explain the Notified Body certification process and level of response required to questions and nonconformities raised
How will I benefit?
- Generate technical documentation that support safe products that perform as intended meeting regulatory requirement, limiting the number of questions from the Notified Body.
- Place products on the market in line with your critical launch dates
- Reduce costs by streamlining the certification process
- You will gain 8 CPD points on completing the course
- Training course notes