Expert workshops
Practical knowledge for life science software teams
Practical training for regulated software teams
Learn from real-world examples, regulatory experts, and 15+ years of software development experience in life sciences and IVD.
BioSistemika’s expert workshops are designed to help your team understand and apply complex regulatory requirements in practical ways.
Whether you’re developing software for FDA-regulated environments or preparing for IVDR compliance, our workshops equip your developers, project managers, and decision-makers with the insights and tools they need to move forward confidently.
Our sessions combine theoretical background with real use cases, technical recommendations, and best practices gained from dozens of successfully delivered projects and systems.
What makes our workshops different?
Accelerated audits and regulatory approvals
Reduced onboarding time for new users or team members
Easier long-term maintenance and upgrades
Proof of quality, safety, and compliance
Available workshops
21 CFR Part 11 Workshop
How to approach the software development or upgrading the existing software to be compliant according to Title 21 CFR Part 11, EU Annex 11 and other relevant regulations.
IVDR Workshop
Understand what is required by IVDR in terms of software and how to approach IVD software development.
Software Development Lifecycle (SDLC) Workshop
Get an insight from experts into how to approach software development and documentation with good SDLC practices for regulated environments, e.g., GxP.
Who are these workshops for?
✔ Software companies entering regulated markets
✔ IVD and medical device developers
✔ Quality and regulatory teams
✔ Product managers and software architects
Let’s talk about your team’s training needs
Contact us to plan an internal session for your company.
