Course
Auditor for Quality Management in the Medical Device Industry - March 08 - 19 2027
€3,150.00
TÜV SUD Academy Quality
Auditor for Quality Management in the Medical Device Industry - March 08 - 19 2027

You are well familiar with the world of medical technology with its numerous standards and laws, including the worldwide demand for an effective quality management system in the manufacture of medical devices. ISO 13485:2016 as an internationally...

Clinical Evaluation Strategy under MDR - October 26th 9:30AM – 12PM EST (3:30PM – 6PM CET)
€345.00
Specific technical skills
/
Public Training
Clinical Evaluation Strategy under MDR - October 26th 9:30AM – 12PM EST (3:30PM – 6PM CET)

How to Define and Justify the Appropriate Level of Clinical Evidence

FDA Inspection - August 20th, 2026, 9AM – 12PM EST (3PM – 6PM CET)
€345.00
Audit and Inspection
/
Public Training
FDA Inspection - August 20th, 2026, 9AM – 12PM EST (3PM – 6PM CET)

This training provides a comprehensive overview of FDA inspection readiness for medical device organizations, focusing on current regulatory expectations, quality management system requirements, and practical inspection preparation strategies....

ISO 14155:2026 Clinical investigation of medical devices for human subjects - GCP
€625.00
Clinical & scientific skills
/
Public Training
ISO 14155:2026 Clinical investigation of medical devices for human subjects - GCP
Duration: 2 x 3 hours
Date: December 14th and 15th 2026, Online
2 × 8:00 AM – 11:00 PM US Eastern Daylight Time (EDT)
2 × 2:00 PM – 5:00 PM Central European Time (CET)

Speaker: Sylvain Biéler

This Good Clinical Practice (GCP) course, certified...
Manager Regulatory Affairs - January 14 - 29 2027
€5,300.00
TÜV SUD Academy Regulatory
Manager Regulatory Affairs - January 14 - 29 2027

The intensive seminar "Manager Regulatory Affairs“ contains all contents for the qualification as "Manager Regulatory Affairs – TÜV". You demonstrate your competence in the areas of European medical device law according to Medical Device...

MDR Expert Compact Seminar - 30 November - 11 December 2026
€4,200.00
TÜV SUD Academy Regulatory
MDR Expert Compact Seminar - 30 November - 11 December 2026

The Compact Seminar “MDR Expert – TÜV” offers comprehensive training on the implementation of the EU Regulation 2017/745 (MDR). You will learn the regulatory requirements of the MDR and understand the changes your company needs to...

Representative for Quality Management in the Medical Device Industry - January 25 - February 5 2026
€3,250.00
TÜV SUD Academy Quality
Representative for Quality Management in the Medical Device Industry - January 25 - February 5 2026

You are already familiar with the standards and laws for implementing an effective quality management system at a medical device manufacturer. ISO 13485:2016 (in the version published in 2021 as DIN EN ISO) as an internationally recognized...

Specialist for Quality Management in the Medical Device Industry - October 26-November 6 2026
€3,150.00
TÜV SUD Academy Quality
Specialist for Quality Management in the Medical Device Industry - October 26-November 6 2026

Regulations in the medical device industry require medical device manufacturers worldwide to implement an effective quality management system. ISO 13485:2016 - or the German version of this standard, which will be published in 2021 as DIN EN ISO...

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