MD / IVD

Software solutions for medical device and IVD manufacturers.

Production, inventory, IT validation, SaMD, clinical and post-market studies: concrete references with medical device companies.

Clients & projects

Targeted use cases for medical devices.

Cancer diagnostics

Dyameo

Deployment of Arianis, our production management solution, for a startup specializing in cancer diagnostics.

  • Production management
  • MD / IVD startup
  • Arianis
IVD inventory & production

Carcidiag

Development of a custom solution to manage the inventory and production of IVD medical devices.

  • Custom solution
  • Inventory
  • IVD production
SaMD component

Oncomedics

Development, IT validation and maintenance of a SaMD digital component for an IVD medical device.

  • Development
  • IT validation
  • Maintenance
Clinical & post-market studies

Client: Major medical device company

Rollout of the Digitalis eCRF and ePRO platform, and training on it, for clinical and post-market studies.

  • Digitalis
  • eCRF / ePRO
  • Training
Resources

The topics that keep coming up at MD and IVD manufacturers.

Validation & GAMP 5 Software categories, V-model, risk analysis and traceability matrix: how GAMP 5 structures a risk-proportionate computerized system validation. PMS / PSUR reports A PSUR links exposure, incidents, trends and actions. Why this data lives in two systems, production and quality, and how to bring it together to produce the report without re-entry. MD / IVD production Batch record, actual consumption, inspections, equipment, deviations and release: what production software must help you demonstrate in a medical device or IVD environment. IVDR & IVD Classes A to D, performance evaluation, PMPF, 2027-2029 transitions, UDI and EUDAMED: what the IVDR changes for the data of an IVD manufacturer. Metrology & equipment Calibration, verification, intervals and out-of-tolerance results: controlling measuring equipment and immediately finding the lots that may be affected. MD / IVD traceability What ISO 13485 and the MDR require of lot traceability, the six practical requirements to meet, and a simple test to see where yours stands. UDI & labeling The structure of the UDI, the recognized issuing entities and the points where labeling errors appear in production. Software & ISO 13485 No software is "ISO 13485 certified": what the frameworks require concerns your records and a validation you remain responsible for. Lab inventory Expiry by lot, supplier lots, quality statuses, metrology and storage conditions: the specifics that a general-purpose inventory tool handles poorly. MES, QMS, ERP or LIMS Four categories of software that people confuse, four different questions, and a comparison table to identify the one you are missing. PMS & vigilance PMS plan, PMSR, PSUR, PMCF/PMPF, vigilance and EUDAMED: what a manufacturer must organize after placing a device on the market, depending on its class. ISO 13485 QMS A QMS is not a piece of software: what the MDR, the IVDR and ISO 13485 ask of the quality system, and how to choose which workflows to digitize first. CAPA & non-conformities Correction, corrective action, cause and effectiveness check: structuring a CAPA process proportionate to risk, without opening a CAPA for every deviation.