Expertise and services
Device design and engineering
Incite Medical expertise and proven project track record encompass the following fields, from device design to component sourcing, manufacturing and OEM.
Electrophysiology (cardiac ablation techniques, catheters and sheaths)
Catheter embedding of functional sensors (mechanical, optical)
Peripheral atherectomy devices
Percutaneous embolic protection devices; radial and transseptal delivery platforms
Cardiac valves (implant and delivery platform design)
Vessel closure systems
Renal denervation devices
Neurological catheters and sheaths, incl. steerable and/or sensor-enabled guidewires
Manufacturing solutions
Sourcing, selection and follow-up of component and assembly/OEM manufacturers, with a focus on complex catheters, precision polymer extrusions, laser machining, electrical discharge machining (EDM), micromolding, precision mechanical components, rapid prototyping
Supplier/third-party partner technical assistance, follow-up and management, to enforce our Client’s project timelines, deliverables and milestones.
Process development
Manufacturing process engineering and optimization
Manufacturing line validation (IQ, OQ, PQ, PPQ)
Q-site, PMA inspection support and consulting
QA/RA compliance
User/Device requirements, per risk management EN ISO 14971
Design Verification protocols and test methods
Suppliers audit (training by NB LNE-GMED)
Support/consulting for :
- QSR 21 CRF Part 820, EN ISO 13485, – SOR 98/282, MDD 93/42/EEC, MDR 2017/745 compliance
- Technical file/ DHF /DMR
- Design review and transfer
- Design and Process validations (per risk management EN ISO 14971)
- Usability (Human factors guideline, IEC 62366)
- Gamma and EtO sterilization validations (ISO 11137, ISO 11737)
- Biocompatibility evaluation/risk assessment), cleaning validations
- CAPA, NCMRs, Customer complaints
- Clinical evaluation (ISO 14155)