Prototypes & Standards-Compliant Testing

MAKE CONFIDENT DECISIONS. VALIDATE CORRECTLY.
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From design model to tested component

RELIABLE RESULTS FOR SAFE DECISIONS

In medical technology, there's no room for guesswork. Before a product goes into mass production, it must be convincing in design, function, and workmanship – technically, regulatory, and economically. That's why we create precise prototypes and conduct standards-compliant tests to ensure product maturity.

At OSCOMED, you can be confident that development, prototyping, mass production, and validation are perfectly coordinated.

Prototyping

FASTER FROM CONCEPT TO REALITY

We produce functional, durable, and practical 3D-printed prototypes from polymers. These serve for design verification, customer approval, or the preparation of regulatory documentation.

  • Prototypes made of polymers (e.g., PEEK) or aluminium
  • Machining processes (CNC turning/milling)
  • Rapid manufacturing for fast feedback
  • Component testing in application or test environments
  • Optional: Fixture construction for testing and trials

Our in-house resources and short lines of communication with toolmaking enable particularly fast development cycles – even with multiple iterations.

Testing procedures & qualification

TESTING WHAT MATTERS LATER

Our prototype and testing processes are aligned with the regulatory requirements of the MDR and are integrated into our certified quality management system according to ISO 13485. In close consultation with our customers, we also consider requirements from standards such as ISO 10993 (biocompatibility) or ISO 11607 (for sterile barrier packaging systems) – tailored to the specific product and its subsequent approval.

  • Geometry and dimensional accuracy testing
  • Functional testing under load
  • Component cleaning and bioburden testing (in cooperation with laboratories)
  • Material analyses, strength tests, visual inspections
  • On request: external testing and documentation support for approvals

Together with your team, we define suitable test plans and support you throughout the standards-compliant testing and release phase.

Benefits for you

PROTOTYPES THAT REALLY HELP
  • Development & prototyping from a single source
  • Technically realistic results (not just theoretical models)
  • Relevant testing in the context of series production
  • Early risk mitigation
  • Valuable decision-making basis for your project team & regulatory affairs