Courses

Clinical evaluation

Date: 15 January 2026, 9.00-14.00 CET
Place: Online (held in Swedish)
Price: 5 800 SEK (excluding local VAT)

Medical devices

Technical documentation for medical devices

Date: 03 February 2026, 9.00-15.00 CET
Place: Online (held in Swedish)
Price: 5 800 SEK (excluding local VAT)

Medical devices

Usability engineering according to IEC 62366-1

Date: 18 February 2026, 9.00-16.00 CET
Place: Online (held in English)
Price: 8 100 SEK (excluding local VAT)

Medical devices

Medical device software process design based on IEC 62304

Date: 04-05 March 2026, Day 1: 9.30-16.00 CET, Day 2: 9.00-16.00 CET
Place: Stockholm, Sweden
Price: 15 200 SEK (excluding local VAT)

Medical devices

Cybersecurity standards for medical devices

Date: 26 March 2026, 8.30-16.00 CET
Place: Online (held in English)
Price: 8 600 SEK (excluding local VAT)

Medical devices

Quality Management System according to EN ISO 13485:2016 – in practice

Date: 15-16 April 2026, Day 1: 9.30-16.30 CET, Day 2: 9.00-16.00 CET
Place: Stockholm, Sweden (held in English)
Price: 14 300 SEK (excluding local VAT)

Medical devices

Internal audits based on ISO 13485 for medtech organizations

Date: 06-07 May 2026, Day 1: 9.30-16.30 CET, Day 2: 9.00-16.00 CET
Place: Stockholm, Sweden (held in English)
Price: 13 900 SEK (excluding local VAT)

Medical devices

Introduction to ISO 15189:2022

Medical devices

Clinical Research under MDR and ISO 14155:2020

Medical devices

PMCF in accordance with MDR and MDCG

Medical devices

Publication of clinical study data

Medical devices

ICH GCP E6 (R3)

Pharmaceuticals

Curricular training for investigators and members of clinical investigation teams/groups

Medical devices

What is required for market access in the US after the new FDA QMSR?

Medical devices

Risk management for medical devices

Medical devices