Contract manufacturing
The controlled production
of your medical devices
ready to be sterilized
An appropriate production tool with capacity
STATICE can ensure the annual production of a few units (e.g. mechatronic devices, implants) up to several tens of thousands of devices (e.g. catheters, silicone parts).
Our two production sites, one located in Besançon (France) and the second in Mauritius, comply with regulatory requirements and offer an adapted industrial response.
STATICE has:
- 4 ISO 7 cleanrooms of 1000 sqm in total
- Mechatronic assembly workshops of 400 sqm in total
These workshops allow the manufacture of various medical devices such as implants, active catheters, active medical devices, in vitro diagnostic devices, laboratory equipment, …
A deep-rooted quality culture
Our production processes are based on a robust Quality Management System, ISO 13485 certified, FDA and ANVISA approved.
STATICE is regularly audited by its customers and Notified Bodies and inspected by the competent authorities.
STATICE guarantees production in accordance with the Device Master Record (DMR) and traceability ensured by our ERP system.
The production, cleaning, sterile barrier packaging and labelling stages are controlled by a dedicated team of 5 quality controllers.
Batch releases are also supervised by two quality technicians
Supply chain team, computerized and centralized management
Physical flows at STATICE are managed through:
- A reception/control/vertical storage area
- A temperature-controlled storage area
- A shipping area to the sterilizer or to the end customer
- A quarantine area
All information flows are managed by our ERP system which covers:
- Purchase orders management (customers and suppliers)
- Inventory management
- Production planning
- Production Records (DHR)
- Quality data management (batch release, certificates of conformity)
Through collaborative planning over 12 to 18 months, we prevent effectively the risks of bottlenecks.
Continuous improvement team
Fully integrated into the STATICE organization, this team:
- Provides ongoing technical support for production
- Ensures preventive/curative maintenance of specific tooling in production
- Supports production ramp-ups
- Pilots productivity actions
- Provides expertise during the R&D and Design Transfer phases
Each product/process change is governed by a documented change control process.
Business continuity
is a priority
To secure production, STATICE has established a Business Continuity Plan
- Workshops spread over several sites and buildings
- Preventive maintenance of critical equipment
- High availability of IT resources
- Computer server replication
- Une démarche Cybersécurité
- Une autosuffisance électrique temporaire