Product Management
A register of your medical devices, MDR classification and the technical documentation of every device in one place.
The Product Management module is a register of all the medical devices you manufacture. Every device has its own record: basic data, MDR classification, regulatory and market data, and variants. Next to the record you keep the device technical documentation in folders based on MDR Annexes II and III. Numbering, folders and pick lists can be adapted to your company.
Why Your Team Needs This Module
The main benefits this module brings to your team’s day-to-day work.
Register of all your devices
A list of the devices you manufacture: ID, name, regulation, class, Basic UDI-DI, status and a legacy device flag. Clicking a device opens its record.
MDR classification stored with the device
Device class, Annex VIII classification rules with a justification, MDA/MDN, MDS and MDT codes, and optionally EMDN and GMDN. All stored in the device record.
Variants and status history
Each variant has its own ID, UDI-DI code and a description of how it differs from the base model. A device status change requires a justification, and the history shows who made it and when.
Technical documentation in folders
Ready-made folders based on MDR Annexes II and III, the declaration of conformity and certificates. You can add your own folders and subfolders or hide the ones you do not use.
Key Features of the Module
What exactly this module can do.
New device
ID assigned according to a numbering scheme you define (e.g. WYR-001), name, trade names, description, intended purpose, status (in development, active, withdrawn) and Basic UDI-DI.
Classification and codes
MDR regulation, class I, Is, Im, Ir, IIa, IIb or III, classification rules 1–22 with a justification, MDA/MDN code, MDS and MDT codes, and optionally EMDN and GMDN codes.
Device characteristics
Sterile device with its sterilisation method, implantable, active, containing a medicinal substance, composed of substances, containing animal or human tissue – with a field for the substance name or tissue type. The administrator can adapt the list of sterilisation methods to the company.
Regulatory and market data
Notified body and its number (if applicable), date of first placing on the market, and the markets and countries where the device is made available.
Variants and models
Variant ID assigned according to the scheme, name, UDI-DI code, differences from the base model and notes, e.g. “Italian market only”.
Documents integrated with the DMS
The technical documentation uses the documents stored in the DMS directly. Document versions, statuses and data are synchronised automatically.
Cloud Security & EU Compliance
AWS architecture & GDPRHow this Module Connects with Other QMS Processes
NexiMed modules work together. Below are the processes related to this module.
QMS Documents
Document names, IDs and versions in the technical documentation come from the DMS
Module Implementation FAQ
Can we keep our own device numbering?
Yes. You define a numbering scheme, e.g. WYR-001, and the system assigns the next numbers to new devices. Variant numbering works the same way.
Is the technical documentation structure fixed?
No. The module comes with ready-made folders based on MDR Annexes II and III, but you can add your own folders, hide the ones you do not use and create subfolders.
How do we mark a device as a legacy device?
When adding a device, you set the legacy device status and can add a comment. The flag is visible in the device register and in the device record.
Which regulations does the module cover?
The module currently supports medical devices under the MDR 2017/745 regulation, covering all device classes and the classification rules set out in Annex VIII.
See Product Management in Action
Schedule an online demo with NexiMed specialists and see how this module can support the processes in your company.
Have questions?
Let's talk about your processes.
Not sure which package to choose? Or maybe you need a custom integration? Our engineers will be happy to help.