Deep understanding of GMP/FDA compliance requirements for medical device manufacturing, providing full-process flexible automation solutions from disposable consumables to high-value implantable devices, building a digital defense line for quality control.
Medical device production is governed by 21 CFR Part 11 and GMP regulations. Each step's operation, parameters, and results must be electronically documented.
From disposable consumables to high-value implants, the SKU count is massive with small batch sizes. Traditional rigid equipment incurs extremely high changeover costs.
Some devices must be assembled in ISO Class 5 (A/B) cleanrooms or Class 10,000 / Class 100,000 environments, with zero tolerance for particulate contamination.
Our Solutions
ESOP visual platform deeply integrated with MES, automatically generating 21 CFR Part 11 compliant electronic batch records, eliminating manual entry errors.
Fenceless collaborative robots handle catheter assembly, end-cap pressing, screw capping, and other fine processes, supporting rapid switching between small batches of multiple specifications.
Integrated OCR and OCV visual verification, 100% inspection of label text, barcodes, and expiration date print accuracy, meeting UDI unique identification requirements.
From raw material inbound to finished product outbound, achieving single-unit full lifecycle traceability. Error-proofing ensures no critical step is ever missed.