Training Features

Regulation 2017/746 (IVDR): Practical Implementation of Technical File Documentation

Join us on 18 and 25 June 2026 for a virtual training that will help you master IVDR technical file documentation and ensure compliance for market access.
Format

Virtual Training

Level

Basic

Date

15 and 17 December 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

José E. Cabrera

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Technical File Documentation under IVDR

Under the In Vitro Diagnostic Regulation (IVDR) 2017/746, manufacturers must maintain comprehensive technical documentation to demonstrate compliance. Properly structured technical files are essential for obtaining and maintaining CE marking and ensuring market access. 

Led by José E. Cabrera, this interactive training helps IVD professionals understand the key requirements for technical file documentation.  
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Comprehensive and well-structured technical documentation is critical for demonstrating compliance under the In Vitro Diagnostic Regulation (IVDR) 2017/746 and securing CE marking for market access.

This virtual training provides medical device and IVD professionals with a clear understanding of the key requirements for IVDR technical file documentation. The course covers essential content, practical guidance for structuring documentation, and best practices for implementation. Participants will receive a certificate upon completion, confirming their knowledge of IVDR technical documentation expectations.
Key Learning Objectives
  • Understand the regulatory requirements for IVDR technical documentation 
  • Learn how to structure and maintain a compliant technical file 
  • Gain insight into clinical and performance evaluation requirements 
  • Understand the integration of risk management and usability engineering into documentation 
  • Learn about labeling, UDI, and EUDAMED compliance requirements 
  • Understand post-market surveillance and vigilance documentation needs 
  • Identify common technical file deficiencies and best practices for compliance 
  • Learn how to prepare technical documentation for Notified Body review. 
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 15 and 17 December 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 18 and 25 June 2026. More information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals responsible for technical documentation 
  • Quality Assurance managers and personnel 
  • R&D and product development teams 
  • Clinical and performance evaluation specialists 
  • Post-market surveillance (PMS) and vigilance professionals 
  • Anyone involved in compiling, reviewing, or maintaining IVDR technical documentation.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory requirements for technical documentation, including IVDR expectations, differences from the IVDD, and the role of Notified Bodies.
  • Structure of a compliant technical file, covering required sections, GSPR mapping, design and manufacturing information, analytical and clinical performance data, and Annex II and Annex III requirements.
  • Performance evidence needs, including performance evaluation, scientific validity, analytical and clinical performance, PMPF, and demonstrating State of the Art.
  • Risk management and usability engineering, integrating ISO 14971, applying IEC 62366 principles, and demonstrating the risk-benefit profile.
  • Labelling and UDI requirements, including IFU content, UDI and EUDAMED, and language compliance.
  • Post-market surveillance and vigilance documentation, including PMS planning, SSCP, PSUR, incident reporting, and field safety actions
  • Additional documentation requirements for certain devices, including those with medicinal products, human or animal tissues or cells, substances, and companion diagnostics.
  • Best practices and Notified Body expectations, including common gaps, preparation tips, and lifecycle maintenance of technical documentation.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

José E. Cabrera

José Enrique Cabrera is a Principal Consultant and US Market Expert at Qserve with more than 25 years of experience guiding medical device companies through complex FDA regulatory pathways, specializing in innovative, first in class, and breakthrough technologies, as well as supporting EU MDR certified manufacturers in their transition to the US market.