Cisteo Medical

France

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Cisteo Medical is a contract development, manufacturing, and regulatory compliance organization (CDMO) founded in 2010 in Besançon, France. Operating within the microtechnology cluster of Franche-Comté and as part of the Agôn Electronics group, the company employs approximately 60 people and specializes in innovative and critical medical devices.

Cisteo Medical bridges design engineering, manufacturing, and regulatory affairs, ensuring that implants, surgical instruments, and active electromedical devices are designed from day one to comply with European CE marking (MDR 2017/745) and US FDA requirements (21 CFR Part 820). The company holds ISO 13485:2016 certification and FDA registration.

Offer

Cisteo Medical provides end-to-end design engineering, regulatory strategy, and contract manufacturing for medical technologies:

Design-Level Regulatory Compliance: Integration of regulatory requirements during early R&D phases, including design controls, traceability matrices, and verification and validation (V&V) protocols.
CE Marking & FDA Filings: Creation, review, and defense of Technical Documentation under EU MDR 2017/745 and drafting of FDA 510(k) and PMA submissions.
Standards Conformance: Risk management according to ISO 14971, usability engineering per IEC 62366-1, biological evaluation/biocompatibility assessments according to ISO 10993-1, and electrical safety coordination.
Cleanroom Manufacturing & Assembly: Micro-assembly, packaging, and cleaning inside controlled environments (ISO 5, ISO 6, and ISO 7 cleanrooms).
Quality Assurance & Audits: Deployment and audit preparation for ISO 13485:2016 QMS, supplier audits, and Qualiopi-certified training for MedTech teams.

Cisteo Medical

Offer

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