Transforming your needs into an innovative medical device

Recognized expertise since 1978

STATICE supports startups, SMEs or major companies as CMDO for all key stages of the development of innovative Class I to III (sterile) medical devices until they are placed on the market:

Specification Definition
Planning
Brainstorming (technical orientation, choice of materials)
CAD Design (Solidworks) and digital simulation
Proof Of Concept / Fast prototyping / Verifications
Industrialization (design and manufacture of tools)
Pre-series / Validations
Technical file
Manufacturing of the first clinical batches (First-In-Human)

The designs meet the requirements of safety, mechanical/electrical performance (fatigue resistance, resistance, sealing, electrical safety / EMC) and miniaturization. They take into account biocompatibility and usability, in particular compatibility with robotic surgical procedures.

STATICE positions itself as a key partner in European and national collaborative projects (ex: ESOHISTO, MSGUIDE).

Our design office is structured around 5 areas of expertise working in synergy. They are in permanent interaction with our customers (reporting weekly period, monitoring of the schedule, exchanging on the project strategy).

Innovations

Mechanical R&D Department

Composed of experienced and multidisciplinary engineers (mechanics, plastics, materials,…), this department ensures the microtechnical design and performance verification of medical devices.

It also ensures the development of tooling (molding, jigs, assembly fixtures) and specific test/control benches.

It relies on CAD/FEA simulation tools (Solidworks), 3D printers (FDM, SLA), in-house assembly means and test equipment (laser metrology, custom test benches, tensile machines, climate chambers, etc.).

It uses biocompatible materials commonly used in medical devices (Silicone, PEEK, Polyurethanes, Nitinol, Platinum-Iridium, Titanium, MP35N, 316LVM stainless steel, synthetic ruby, etc.).

Mechanical prototyping workshop

Our machine shop, composed of 4 prototypists, is a strategic advantage for development projects because it offers great responsiveness in:

Manufacturing prototype parts
Making tools
Making bench test
Fine tuning prototypes/tooling in real time
Supporting design iterations
Assurer la maintenance des posages/outillages

Machine park: 4-axis CNC milling, EDM and wire EDM lathing, metrology resources, …

Electronic R&D and Software Development Department

Electronic developments apply to active medical devices (implantable or not) but also address test benches (R&D), semi-automated production tools and control systems in production.

The team, composed of experienced engineers and technicians, is responsible for:

PCB design (drawing up diagrams, routing)
Prototyping (PCB manufacturing, wiring)
Microcontrollers firmware development
Software development of Human-Machine Interfaces (Windows, Android, iOS)
Performance tests

It is capable of taking into account energy management (including RF transmission) and implementing wireless communication systems (Bluetooth, RF, NFC).

The electronic circuits integrated into the devices are protected by sealed encapsulations obtained by epoxy potting, tropicalization, parylene treatment and integration into a laser-welded titanium box for the implanted devices.

Validation Department

10 biomedical engineers are in charge of the regulatory compliance of the devices developed.

This team’s mission is to plan and implement V&Vs:

Rédaction des protocoles et rapports de validation
Performing performance tests before/after aging and sterilization
Electrical validations (IEC 60601, EN 45502, ISO 14708)
Software validation ( IEC 62304 , ISO 80002)
Validation of special manufacturing processes (IQ, OQ, PQ)
Cleaning validation (ISO 19227)
Sterilization validation (ISO 11135/11137)
Biological evaluation (ISO 10993)
Packaging validation (ISO 11607)

The validations department is also responsible for:

Writing the Device Master Record (DMR):
- Production plan, manufacturing/inspection instructions, follower sheets
- Purchase specifications
- Label proofs (ISO 15223)
The creation of bills of materials in the ERP for complete traceability
Product/process change control

Regulatory Affairs Department

In addition to our technical offer, STATICE offers regulatory support for the approval of the medical device developed.

From the initiation of a development, the project team takes into account the critical applicable standards such as ISO14971 (risk management) and ISO10993 (biocompatibility).

Several regulatory issues can be adressed by our team (regulatory strategy, technical file, support in exchanges with the competent authorities and notified bodies).

Our team can also set up or audit your QMS.