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About

We support our customers in the medical device industry in all phases of the product life-cycle. 

Together with our partners we can assist you with a complete framework for regulatory services, device documentation, tech filing and tools for verification and validation. 


 

Project examples

Ophthalmology / Refractive Surgery

Ophthalmology / Refractive Surgery

Project: New injector system for intraocular lenses (IOL)

Tasks: Product development, quality management and regulatory services

Client: Start-up company in Germany

Neurosurgery

Neurosurgery

Project: Development of an innovative access port for brain surgery

Tasks: Product design including prototyping, quality management, regulatory advisory

Client: Start-up company in the Netherlands

Cardiac Surgery

Cardiac Surgery

Project: Heater cooler units

Tasks: Redefinition of disinfection methods including validation and final assessment.

Client: Market leader in medical devices for cardiac surgery

Neurosurgery

Neurosurgery

Project: Redesign of an extra-ventricular drainage system

Tasks: Design, risk management and prototyping

Client: Manufacturer of ventricular pressure monitoring devices and catheters

Orthopedics / Surgery

Orthopedics / Surgery

Project: Design Transfer: Pulse lavage system

Tasks: Product development and design transfer (injection moulding and product assembly)

Client: Manufacturer of biomaterials and surgical accessories

Anesthesia

Anesthesia

Project: DHF Remediation project

Tasks: Restructuring the design documentation, identification of gaps and gap closure

Client: Market leader anesthesia / respiratory care

Orthopaedics

Orthopaedics

Project: Design Transfer: Bone cement mixing device

Tasks: Product design, technical file development, design transfer

Client: Market leader in biomaterials

Cardiac Surgery / Heater Cooler Unit

Cardiac Surgery / Heater Cooler Unit

Project: Development of an innovative heater cooler unit for cardiac surgery

Tasks: - Quality Management - Regulatory Affairs - Design Validation

Client: Start-up company in the Netherlands

Endoscope Reprocessing

Endoscope Reprocessing

Project: Technology assessment for an innovative sensor unit

Tasks: IP research, concept development

Client: Swiss medical device manufacturer

Implant Manufacturer

Implant Manufacturer

Project: ISO 13485 certification

Tasks: Review of existing QM procedures and mock-audit

Client: Contract manufacturer

Drug Device Combination

Drug Device Combination

Project: MDR Readiness

Tasks: Review and preparation of device documentation to fulfill MDR requirements for combination products

Client: Pharmaceutical manufacturer

MRT Imaging

MRT Imaging

Project: Design transfer: Peripheral device for MRT

Tasks: Planning and realization of serial production, layout planning, process qualification

Client: Medical device contract manufacturer

IVDR Compliance

IVDR Compliance

Project: IVDR Design Control Consulting

Task: Gap analysis, documentation update and regulatory compliance engineering

Client: Biotech company in Germany

Drug Inhaler

Drug Inhaler

Project: Development of a novel powder inhaler system

Tasks: Project management and DHF preparation including risk management

Clients: Pharmaceutical company

Infusion Pumps

Infusion Pumps

Project: Test Method Development

Task: Development of design verification test methods

Client: Market leader for infusion medical devices