How to write a technical file

Program overview

• Annex II technical documentation – pre-market
• Annex III technical documentation – post-market
• Regulatory Lifecycle concepts, embedding PMS and PMCF
• PSUR & SSCP requirements
• Case studies
• Questions & Answers
• Evaluation of the Course and closing

Learning objectives

• What do the authorities (Notified Body, FDA, CFDA) expect?
• Manage the creation of technical files for the certification process for the European Union
• Practical examples
• Create technical documentation to support the product throughout its lifecycle. 
• Learn to structure data and build technical documentation under MDR
• Understand the full impact of the new EU-MDR on PMS and PMCF principles in continued market approval
• Know how to apply PSUR and SSCP
• Understand how to build and use checklists, tools, and templates

Who should attend?

• RA manager
• RA director
• QA manager
• QA director
• International registration department

Costs

We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.