Courses

IEC 62366 - Medical Device Usability

Date: 07 October 2026, 9.00-16.00 CET
Place: Online (held in English)
Price: 8100 SEK / 745 € (excluding VAT)

Medical devices

Clinical evaluation

Date: 09 October 2026, 9.00-14.00 CET
Place: Online (held in Swedish)
Price: 6100 SEK (excluding VAT)

Medical devices

Medical device software process design based on IEC 62304

Date: 25-26 November 2026, 09.30 - 16.00 (Day 1) / 09.00 - 16.00 (Day 2) CET
Place: On-site (held in English)
Price: 15,200 SEK / 1405 € (excl. VAT)

Medical devices

Quality management system according to EN ISO 13485:2016 – in practice

Date: 1-2 December 2026, 09.30 - 16.30 (Day 1) / 09.00 - 16.00 (Day 2) CET
Place: On-site (held in English)
Price: 14,300 SEK / 1320 € (excl. VAT)

Medical devices

Internal audits based on ISO 13485 for medtech organizations

Date: 8-9 December 2026, 09.30 - 16.00 (Day 1) / 09.00 - 15.30 (Day 2) CET
Place: On-site (held in English)
Price: 13,900 SEK / 1160 € (excl. VAT)

Medical devices

Regulatory Essentials in Health Tech - Full training series

Date: On-demand
Place: Online
Price: 1900 € (excluding VAT)

Medical devices

ICH GCP E6 (R3)

Date: On-demand
Place: Online
Price: 90 € (excluding VAT)

Pharmaceuticals

Custom regulatory & clinical strategy workshops

Date: Flexible schedule
Place: On-site or online
Price: Based on scope

Medical devices

Custom training for your organization

Date: Flexible schedule
Place: On-site or online
Price: Based on scope

Medical devices

Introduction to ISO 15189:2022

Medical devices

Clinical research under MDR and ISO 14155:2026

Medical devices

PMCF in accordance with MDR and MDCG

Medical devices

Publication of clinical study data

Medical devices

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

Medical devices

Introduction to ISO 13485

Medical devices

ISO 13485 standard internal auditing

Medical devices

Cybersecurity standards for medical devices

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

Technical documentation for medical devices

Medical devices

ISO 15189 standard internal auditing

Medical devices