Technical and compliance servicesomsbar 3x squares icon

Demonstrating compliance with harmonised and international standardsomsbar 3 squares icon

EU Directives indicate that demonstrating conformance with applicable harmonised standards can be used without further justification as a means to demonstrate compliance with relevant essential requirements contained in the directives. Therefore compliance testing is a key strategy in obtaining CE Marking.

Omsbar works in conjunction with the specialist test houses to translate the product specification and functionality into specific test requirements and conditions, communicating these requirements in technical terms to the test house in the form of a test protocol. Such interfacing is usually necessary because companies do not understand the test house requirements and obligations and test houses very often do not understand the principles and key features of client products and how they operate. (Particular stumbling blocks can be Essential Performance Requirements and Biocompatibility Validation).

Non-product related standards include for instance IEC62304 (Software Lifecycle Management) and ISO14155 (Clinical Investigation). We ensure that all the work that we do with clients is in compliance with these applicable standards to provide a smooth path through technical file and 510k assessment. We use our accredited ISO13485 quality management system to provide direct objective evidence of compliance with these standards, and our SOPs and Work Instructions embody all such standards' requirements accordingly

Omsbar capabilityomsbar 3 squares icon

A prototype component is being measured on a shadow graph;  this device is capable of measuring to 1 micron resolutionCompliance testing can be provided in the following areas:

  • Electro-Magnetic Compatibility  (EMC)
  • Electromedical Equipment Safety and Essential Performance
  • Sterilisation
  • Bio-compatibility

Where necessary, test houses and laboratories are contracted to perform specific testing necessary to demonstrate compliance with harmonised standards. Omsbar identifies the applicable standards, evaluates and identifies test requirements, designs the tests, negotiates the test protocol and manages the subsequent presentation and assessment of the results.