Business Central for Medical Device Manufacturers - What Applies?
By Thomas Brünger, Managing Partner
Business Central can serve as the ERP backbone for a medical device manufacturer, but it is not compliant with medical-device regulations out of the box. Compliance comes from configuring and validating the system against the applicable standards — it is not a property of the licence.
What applies
The quality system is governed by ISO 13485 and, for the US market, FDA 21 CFR Part 820 (the Quality System Regulation, now converging with ISO 13485 under the QMSR). Electronic records and signatures fall under 21 CFR Part 11, and EU MDR 2017/745 adds traceability and UDI (Unique Device Identification) expectations. The ERP's job within that framework is material and production control, lot and serial traceability including UDI, and the records that evidence it.
How Business Central fits
Business Central handles the ERP scope — procurement, production, inventory, lot/serial and UDI traceability, and the device history that ties them together — while design controls, CAPA, and complaint handling usually sit in an integrated QMS. The whole computerised system is validated with a risk-based approach: see computer system validation step by step and 21 CFR Part 11 and Business Central.
Independent architecture governance can confirm the traceability and Part 11 design meet the standard before an audit.
Frequently asked questions
- Which regulations apply to an ERP in medical device manufacturing?
- ISO 13485 and FDA 21 CFR Part 820 (the Quality System Regulation, converging with ISO 13485 under the QMSR) for the quality system; 21 CFR Part 11 for electronic records and signatures; and EU MDR 2017/745 traceability and UDI expectations.
- Does Business Central replace a QMS for medical devices?
- No. Business Central covers the ERP scope — materials, production, lot/serial and UDI traceability, device history. Design controls, CAPA, and complaint handling typically live in a QMS that integrates with the ERP.