Technical Documentation Academy – EU MDR and EU IVDR
About This Course
Immerse yourself in how modern notified bodies assess technical documentation to understand the systematic methodology used to screen and review product-specific risks, pre-clinical data and the clinical evidence generated and gathered.
The review of technical documentation has become more frequent and thorough based on the changes in the competency requirements and scrutiny requirements driven by the European medical device and in vitro diagnostic device regulations.
Delays caused by incomplete, inadequate or inconclusive technical documentation have led to products being unavailable to the market, commercialization delays and unanticipated costs. Understanding what constitutes a good technical file submission and how notified bodies review them helps business, product and regulatory leaders submit better documentation.
Key Learning Objectives
At the end of NSF’s technical documentation academy training, you will understand:
- The structure and content of technical documentation
- The stages of technical documentation review
- How reviewer skills and competencies are aligned to notified body operations group (NBOG) codes
- How to undertake a screening review
- How state-of-the-art influences the review process
- Building checklists and evaluation strategies for pre-clinical evidence
- How reviewers undertake a risk-based review
- The golden “threads” within technical documentation and how IFU, risk management, general safety and performance requirements (GSPRs), clinical evidence and post-market surveillance plans are reviewed
- How the product and clinical reviewers determine and baseline state-of-the-art and a high level of protection
- Evaluating clinical evidence
- Establishing a system for tracking and trending notified body feedback from the review process
Technical Documentation Course Outline
The course is structured over three days and leverages your own technical documentation. As the product and clinical review takes place remotely, our course is virtual to simulate the desktop assessment. Our tutors take you through the process of screening, sampling and evaluating various elements of technical documentation in groups that are balanced to be representative of the knowledge, skills and experience of notified body reviewers.
Groups examine technical documentation and write up their findings with the same types of questions, clarifications or non-conformities issued by a notified body during the review process.
Highly experienced ex-notified body personnel and tutors with extensive experience in coaching and mentoring review teams facilitate the group. The groups conduct literature searches and review standards, guidance documents and publications that define requirements for the review. Each group presents nine feedback sessions allowing time for discussion, feedback and critical assessment.