How much does it really cost to build a certified SaMD?
Torsdag 7 maj 2026 10:20 - 10:45 Innovation Area
Föreläsare: Przemek GrzywaSpår: Innovation area
Developing Software as a Medical Device is a complex regulated journey that requires more than writing code. This presentation will walk participants through the end to end process of building and certifying SaMD in Europe. It will begin with defining intended use and aligning the product concept with regulatory pathways. It will then cover design controls, risk management, usability engineering and documentation requirements that shape the development process for all SaMD classes.
The session will explain the key differences between class I products and higher classes which face stricter expectations such as mandatory quality management systems, formal verification and validation, clinical evaluation with robust evidence and oversight from a notified body. Attendees will learn how these differences impact project duration, budget and team structure.
The presentation will also describe the certification workflow under European regulations including technical documentation, conformity assessment and preparation for CE marking. Based on real projects delivered in Europe, the talk will provide indicative minimum timelines and cost benchmarks for bringing a compliant SaMD to market. This practical perspective will help organisations understand the true scope of investment, plan more effectively and reduce regulatory risks early in the process.
Ämne
Teknik
Seminarietyp
Live + på plats
Föreläsningsformat
Presentation
Föreläsningssyfte
Orientering
Kunskapsnivå
Fördjupning
Målgrupp
Chef/Beslutsfattare
Tekniker/IT/Utvecklare
Forskare (även studerande)
Nyckelord
Exempel från verkligheten (goda/dåliga)
Innovation/forskning
Dokumentation
Appar
Föreläsare
Przemek Grzywa Föreläsare
Co-founder
Revolve Healthcare
Building 10 MDR digital products right now.
With over seven years of experience in medical software development, I am the co-founder and co-CEO of Revolve Healthcare, a company that helps life science and healthcare companies design, build, and certify (ISO/MDR/CE) their digital products.
We have extensive experience working with international medical companies and startups, and we are certified with an ISO 13485 for "Software design and development services for the medical devices industry". Our services are also compliant with both EN IEC 62304 and EN IEC 62366 standards.
Revolve Healthcare has been recognised as one of the fastest-growing healthcare companies in Europe, according to the FT1000 ranking by the Financial Times and Statista (2025 edition).
My passion for healthcare stems from my personal and family background.
I have spent the last 20 years as a patient in different doctor's offices and hospitals, and I come from a medical family. My dad was a surgeon and my mom was a nurse with a medical degree. I understand the pains and needs of both patients and healthcare professionals, and I aim to create solutions that improve quality of life both for patients and medics.
I am also an active speaker, mentor, and expert in various healthcare innovation and entrepreneurship programs, such as SPARK-BIH at Charitè, EIT Health, and Vision Health Pioneers Incubator.