Omsbar Medical Device Design Manufacturing and Regulatory Services



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Verification and Validation
Omsbar provides verification and validation services to identify and obtain necessary test data for demonstrating product compliance and compatibility to regulatory authorities. Examples of standards routinely used by Omsbar to assess products are:
  Electronic and Electrical Medical Devices
  IEC60601-1 (General Requirements for Safety)
  IEC60601-1-1 (Requirements for Systems)
  IEC60601-2 (Electromagnetic Compatibility (EMC) Requirements)
  IEC60601-4 (Programmable Systems Requirements)
  IEC60601-2-X Specific Requirements standards
  Sterile Single Use Devices
  ISO10993 Biocompatibility
  ISO11135, 11137 Sterilisation
  Performance standards
  ISO8536 Infusion Lines
  ISO10555 Catheters
Specific realisations of standards such as AIMI, ANSI, UL, CSA etc can be accommodated.
Omsbar teams with agencies and organisations expert in highly specialised areas of testing and verification. Before starting, Omsbar conducts necessary research of International Standards, compiles a testing rationale and the necessary protocols for demonstrating compliance, then ensures that work is performed and documented in a timely and fully traceable fashion.