OptoBioMed

As your competent OEM partner, we support you to turn your ideas into a product, and we are your partner with regard to make-to-order manufacturing and service.  

Everything from a single source – the most efficient way for you to receive your device!

Why not benefit from our experiences?

  • Long-term experiences in developing and manufacturing products for life science and medical engineering
  • The highest quality standards – certified, checked, and applied daily!
  • Precise controlling in order to implement projects by observing schedule and cost budgeting  
  • Certified according to DIN EN ISO 13485
  • Company has passed FDA audit

Our developments are used in the following fields:

  • optical diagnostics, e.g. fluorescence-detection and raman-spectroscopy
  • Imaging fluorescence
  • Immunodiagnostics
  • Molecular diagnostics
  • Dental medicine
  • Realtime-PCR
  • Dermatology
  • illumination systems
  • in vitro-diagnostics

Convince yourself of our skills in development and production and/or our successful solutions for our customers (projects)

DEVELOPMENT

  • Standards-compliant planning and documentation of the whole development process (
  • design history file)
  • Software life cycle processes according to DIN EN 62304:2007-03
  • Process and device validation
  • Type tests, e.g. climatic test, storage test, vibration test, and transport test


PRODUCTION

  • Process monitoring, defect tracking, CAPA, 8D (device history record)
  • Simulation and creation of test strategies and their implementation
  • Development and making of complex test instruments
  • Change control management
  • Monitoring of the suppliers



With our customers, we make agreements on quality assurance including special requirements with regard to the devices and their approval.           

 

 

Certification

Projects

Career

Who we are

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