Medical devices is one of manufacturing's most heavily regulated fields: the ISO 13485 system, FDA 21 CFR Part 11 electronic signatures / audit trail, UDI unique identification, the CAPA workflow, and sterilization validation. SBK MES turns these compliance requirements into out-of-the-box capabilities.
High compliance demands and high cost of failure require every step to be traceable and provable
21 CFR Part 11 requires electronic signatures on all key operations → electronic signatures across all modules + two-factor authentication
Every data change must trace the who / when / why → full-field audit logs, never deleted
FDA requires UDI unique identification for devices → DI + PI dual-segment coding + auto-marking and GUDID upload
Deviations / complaints / recalls must go through CAPA → templated CAPA workflow + tracking + effectiveness verification
Each sterilization batch needs parameters + chemical indicator + biological indicator → sterilization parameters auto-recorded + three-way validation
Each batch must have complete DHR documentation → MES auto-generates the DHR, including full-operation parameters / inspection / signatures
FDA 21 CFR Part 11 is the compliance ceiling of the medical / pharma industry: electronic records and signatures must carry the same legal force as paper signatures, and all changes must be traceable. SBK MES makes this compliance a built-in capability, with no extra integration needed.
FDA requires devices to carry a UDI unique identifier, comprising the DI (device identifier) + PI (production identifier). SBK MES closes the full UDI loop — generation / marking / database submission — including integration with the GUDID / EU EUDAMED databases.
Each step signed · retrievable for audit
ISO 13485 requires all deviations / complaints / nonconformities to go through CAPA: corrective actions + preventive actions + effectiveness verification. SBK MES templates the CAPA workflow, with every step traceable and signed, to the auditor's satisfaction.
Syringes / catheters / surgical kits, with strong traceability + sterilization validation + UDI
Bone screws / cardiac stents — Class III devices with the strictest traceability down to each SN
Reagent kit batches bound to standard curves, with expiry + storage/transport temperature traced throughout
Large medical equipment in ETO mode, with installation & commissioning reports + integrated after-sales repair
These MES modules together form the medical-device solution
Sign up to explore ISO 13485 / 21 CFR Part 11 compliance capabilities for free, or book a consultant demo