Medical Technology

Mechatronics Expertise

  • Electronics (PCBAs, Inductive Coils, Cable Assembly)
  • Mechanics (Sheet Metal Processing, Machining)
  • Production, Assembly and Testing of Single Parts, Modules, Devices and Systems

For

  • Life Sciences & Diagnostics (IVD)
  • Therapy
  • Respiratory
  • Pharmaceuticals/Drug Delivery
  • Ophthalmology
  • Homecare & Wearables
  • Surgery
  • Dental
  • Imaging & Monitoring

Service and Support along the Entire Lifecycle

  • Development (Design Support, Hardware and Software Development, Mechanics Development, Simulations, etc.)
  • Consultation (DFx, NPI Management, Industrial Engineering, Digital Factory, Tooling and Test Equipment Design and Construction)
  • Production (Industry 4.0, Comprehensive Traceability, Low-Volume-High-Mix to High-Volume-Low-Mix Production, High-tech Production technologies, Cleanroom Production, Lean Manufacturing, Global Production Sites, etc.)
  • SCM (Material and Supplier Management, Obsolescence Management, Material Analysis Technology, Worldwide Delivery, etc.)
  • Services (After-sales, Long-term Storage, Last-Time-Buy, Repair, Refurbishment, Document Archiving, etc.)

Research & Development

  • Design support
  • Hardware and software development
  • Mechanics development
  • Simulations

Consultation

  • DfX (DfT, DfM, DfC, DfSS, etc.)
  • NPI management
  • Industrial Engineering
  • Digital factory
  • Tooling and test equipment design and construction
  • Qualifications

Production

  • Industry 4.0
  • Comprehensive traceability
  • Production of High-Mix/Low-Volume to High-Volume/Low-Mix, high-tech manufacturing technologies
  • Controlled area/cleanroom production, Lean Manufacturing
  • Global manufacturing sites

SCM

  • Material and supplier management
  • Obsolescence management
  • Counterfeit component protection
  • VMI
  • CMI
  • Logistic solutions
  • Material analysis technology
  • Global delivery

Services

  • After-sales
  • Long-term storage
  • Last-Time-Buy
  • Repair, refurbishment
  • Document archiving

Satisfying Regulatory Requirements

  • ISO 13485
  • EN 60601
  • Medical Devices in Classes I, IIa, IIb, in accordance with 93/42/EEC
  • GMP, GDP
  • US FDA compliance (QSR 21 CFR 820)
  • Japan PMDA compliance (Accredition of Foreign Manufacturers)
  • Korea MFDS compliance (Certificate of GMP)
  • ISO 9001
  • ISO 14001
  • Additional Certifications