Who it’s for
Who should attend
Regulatory affairs staff, technical authors, design and development engineers, quality staff, project managers, and Persons Responsible for Regulatory Compliance who own or review technical documentation.
Curriculum
Course modules
- Purpose of technical documentation and who reads it
- MDR Annex II: structure and required content
- Device description and specification, including variants and accessories
- Information supplied by the manufacturer: labels, IFU, packaging
- Design and manufacturing information
- General Safety and Performance Requirements checklist: evidencing each requirement
- Benefit-risk analysis and the risk management file
- Product verification and validation: biocompatibility, sterilization and shelf life, electrical safety and EMC, software, usability, bench and animal testing
- Clinical evaluation report and supporting clinical data
- MDR Annex III: post-market surveillance documentation, PMS plan, PSUR and PMCF
- Structuring documentation for reuse under the IMDRF Table of Contents
- Document control, versioning and keeping documentation current
- Frequent notified body deficiencies
Outcomes
What you’ll be able to do
- Build a complete technical documentation set from scratch
- Evidence every GSPR with appropriate objective evidence
- Anticipate and avoid common review deficiencies
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Construction of Technical Documentation”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.