SaMD Development Support
Support for software that may qualify as Software as a Medical Device. Qualification depends on intended use and is assessed per product. We do not grant clearance or certification.
Disclaimer: Qualification as SaMD depends on intended use and applicable frameworks; assessed per product. QData Intelligence does not grant regulatory clearance or certification.
When this is needed
- Intended use may place software in a medical device / SaMD category
- Engineering and RA need a shared plan before claims harden
- Documentation and risk controls must catch up with product speed
Methodology
- Intended use workshop — claims, users, clinical vs non-clinical language (client-owned)
- Pathway framing — what may apply; what remains uncertain; owners for assessment
- Product & documentation plan — engineering collaboration suited to regulated software
- Coordination — link to device readiness and regulatory writing as needed
- Client decision — qualification and submissions remain client responsibilities
See How we work and Medical software.
In scope
- SaMD-oriented product and documentation planning support
- Engineering collaboration suited to regulated software
- Coordination with regulatory documentation and device readiness workstreams
Example deliverables
- Intended-use and boundary clarification notes
- Planning artefacts for engineering and documentation tracks
- Inputs for client-owned qualification and QMS work
Out of scope
- Declaring a product is SaMD without client-owned assessment
- Claiming “our SaMD is approved”
- Acting as a notified body, certification body or regulator
- Clinical care or diagnosis
Related
Medical software · Regulatory support · Device readiness · Digital health
Ready to discuss a programme?
Tell us about your organisation and the type of support you need. Do not send PHI or confidential regulatory packs through the public form.