Public courses

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.

Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.

This practical masterclass helps AI start-ups, medical device manufacturers and development teams determine when software qualifies as a medical device, plan EU market access, build proportionate quality and technical documentation, and define the clinical evidence needed to support intended purpose, claims, safety, performance and clinical benefit.

An overview of QRM and RCI and the respective regulatory expectations. Common tools and methods for the Pharma and Medical Device industry.

This fast-paced webinar will cover the details of application of Sampling without the burden of statistical complexity.

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!

Learn how to accelerate medical device development, approval, and post-market activities with compliant use of LLMs.

Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.

Get tools for clear communication about e.g. requirements and expectations in different situations. Be seen as a positive leader that inspires quality work.

Get fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed and avoid the most common pitfalls.

Learn about the IEC 62304 requirements throughout the lifecycle of software, how it integrates with Risk Management activities and the need for documentation.

Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.

Utbildning om de FDA och EU-regler och tolkningar som berör datoriserade och automatiserade system vid läkemedelstillverkning: 21 CFR 11 och EU GMP Annex 11

This course provides a complete, practical roadmap to developing and validating compliant medical AI software. Learn how to bridge EU AI Act requirements, EU MDR, and FDA expectations across the entire product lifecycle—from data governance and risk controls to predetermined change control plans (PCCP) and post-market surveillance.