Digital services

and solutions for

an emerging market

Medtech - Pharma - Lifescience

Due to the change in age structure as well as in the people’s awareness paying more attention to their health, medical technology is becoming evermore important as a link between the technical and medical sector. Strama-MPS responds to this need within the Technology Unit and offers versatile solutions with its services.

Reference project medical technology

Assembly line for assembly and testing of EOS inserters for insulin pumps

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Services

  • We develop and manufacture automated assembly lines and test systems for you that produce medium up to large volumes in a clean
    room
  • Production of individual parts up to small and medium batch sizes on our extensive machine park
  • Assembly and commissioning of mechatronic assemblies and components
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Competencies

  • Consistent Good Engineering Practice (GEP) for order processing
  • V-Model as basis
  • Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based on a validation master plan
  • Implementation of valid standards (e.g. EU-GMP guide, GAMP 5, FDA 21 CFR part 11)
  • Active change management
  • Complete traceability matrix for logical traceability
  • GMP-compliant documentation
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You benefit from our intensive focusing on special expertise in

  • FMEA
  • Risk analysis
  • Quality assurance
  • Data analysis
  • Plant simulation
  • Line Data Server with MES Integration

Contact Persons

Martin Ebner

Chief Technology Officer (CTO)
Technology Unit

P +49 9421 739-441

LinkedIn
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Fabian Hornburger

Quality Engineer 

P +49 9421 739-522