Haemodialysis patient management SaMD
A software device for haemodialysis centres needed a complete quality management system and technical documentation that met EU MDR — while design and development sat with a separate development partner.
- Device
- Patient management SaMD for haemodialysis centres
- Classes and markets
- EU MDR Class IIa · Malaysia MDA Class B
- My role
- QMS lead and regulatory documentation, manufacturer side
- 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
Software as a Medical Device used in haemodialysis centres. It stores patient information, including clinical conditions, dialysis procedures, prescriptions and medications, and also supports patient visit scheduling and clinical staff shift management.
Starting point
The manufacturer had no quality management system. Design and development were done by a separate development partner, which the manufacturer treated as a critical supplier. Its technical documentation had to meet EU MDR requirements as well.
What I did
- Built the QMS from scratch, aligned with ISO 13485 and EU MDR, including all required SOPs and templates.
- Worked with the development partner so that its technical documentation met EU MDR requirements, and coordinated between the manufacturer and the partner.
Who did what
| Party | Responsibility in this project |
|---|---|
| Manufacturer | Owned the device and the QMS; approved procedures and kept the records. |
| Development partner | Design and development of the software and its development documentation. |
| Me | QMS design and documents, alignment of the partner’s documentation with EU MDR, coordination. |
| Notified Body and MDA | Assessment and certification under EU MDR; registration in Malaysia. |
Outcome
- EU MDR certification of the device as Class IIa.
- Registration with the Medical Device Authority (MDA) in Malaysia as a Class B device.
- A complete QMS with SOPs and templates, and supplier documentation aligned with EU MDR.
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