An NSF International Company Medical Device Conformity Assessment - Preparing and Managing Technical Documentation
PrintTo analyse, evaluate and prepare documentation for a regulatory submission with assurance of product safety
Dates:
Monday 18 to Wednesday 20 November 2025
Venue:
AMP Technology Centre, Sheffield, UK
Cost:
£1800.00 excl. VAT
Type: Medical Devices
About this course
Background
By engaging successfully with this module a student will be able to
- 1.- Critically analyse the medical devices Directives requirements for technical documentation.
- 2.- Evaluate the benefits associated with using Information Technology to manage product technical information within an organisation.
- 3.- Determine what data is required to ensure compliance with the essential safety and performance requirements.
- 4.- Integrate the documentation requirements from the IMDRF guidance on NbMed documentation to create effective summary document
What You Will Learn
You will develop in-depth knowledge, understanding and competence through a combination of lectures tutorials, course work and self- study. Lectures will be used to impart underlying principles and factual knowledge. The tutorials sessions will be used to explain and extend difficult concepts introduced during lectures. Independent and group literature research will introduce you to the literature on current Medical Devices practice. The tutor will also give guidance on the material for further self- directed study.
