Life sciences
Research-administration standards for medical device companies
Medical-device R&D — across diagnostics, therapeutics, implants, software-as-medical-device (SaMD), and AI-enabled devices — operates inside FDA 21 CFR, EU MDR / IVDR, and increasingly under FDA AI/ML Action Plan + EU AI Act. Investigator-initiated studies often produce peer-reviewed publications requiring CRediT, ICMJE, and ORCID compliance.
~$590B global market (2024)
What this sector cares about
Key research-administration concerns
- Software-as-medical-device (SaMD) attribution + version pinning
- AI / ML model card disclosure (FDA AI/ML Action Plan + EU AI Act)
- Real-world evidence (RWE) study CRediT statements
- Sponsor-investigator vs sponsor-initiated study contribution patterns
- IDE / IND device-investigator disclosure
- CDISC SDTM mapping for device-trial data
Standards in play
Relevant standards beyond CASRAI
- CRediT
- ICMJE
- CDISC
- ISO 14155 (clinical investigation of medical devices)
- FDA SaMD
- EU MDR
- FAIR data
- FAIR4RS
Typical actors
Who's involved
- Sponsor (device manufacturer)
- Principal investigator
- CRO
- FDA / EMA / MHRA reviewer
- Software engineer (SaMD)
- Clinical engineer
Going deeper
