AI-assisted dental X-ray software
The legal manufacturer of an AI dental imaging product needed a QMS and one coherent technical file — while design, testing and QMS preparation were split across three suppliers.
- Device
- Software for diagnosing and annotating dental X-ray images, manual and AI-assisted
- Frameworks
- UKCA (UK MDR 2002) · EU MDR Class IIa
- My role
- QMS implementation and technical documentation, working for the legal manufacturer
- When
- 2024, before TrustedTraceMed was founded
This project was delivered in a role I held before founding TrustedTraceMed. The client is not named. The description is limited to what can be shared.
The product
A medical device that helps dental professionals diagnose and annotate X-ray images. It offers both manual and AI-assisted diagnostic functions to help clinicians identify dental pathologies.
Starting point
The legal manufacturer was responsible for the device but relied on three suppliers: a critical supplier for design and development, a supplier for performance and security testing, and a third supplier for QMS preparation. Each produced its own deliverables, and all of them had to fit into one technical file.
What I did
- Helped the legal manufacturer implement its QMS.
- Coordinated the regulatory work of the three suppliers so that their deliverables met the requirements for UKCA marking and EU MDR.
- Reviewed and approved the technical documentation coming from each supplier and brought it together into one submission package.
Who did what
| Party | Responsibility in this project |
|---|---|
| Legal manufacturer | Responsible for the device and its QMS; final approval of the documentation. |
| Three suppliers | Design and development; performance and security testing; QMS preparation. |
| Me | QMS implementation support, supplier coordination, review and approval of technical documentation on the manufacturer’s side. |
| Assessment bodies | Conformity assessment for UKCA marking and EU MDR certification. |
Outcome
- UKCA marking for Great Britain and EU MDR certification as a Class IIa device.
- One technical file assembled from the deliverables of three independent suppliers.
Working with several suppliers on one AI device?
Let’s map who owns which part of the technical file in a free 30-minute call.