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Services you can trust - - -

  • Safety Standard requirements interpretation for Medical, Lab/Instrumentation, and Information Technology Equipment

  • Tests according to Safety Standard requirements at customer site

  • Completion of Test Reports

  • Findings Report and design process review for Safety Standard compliance

  • Establish a compliance design process

  • Support with global registration documentation

  • Review of marketing documents, user manuals, labels, customer facing documents, etc for Safety and Regulatory Affairs compliance (English and German)

  • Review Risk Management documents

  • Support with developing a Risk Management process

  • Consulting on Usability requirements

  • Review and support of the Medical Software development process

  • Review of safety relevant software according Safety Standards requirements

  • Prepare and support global market access documents

  • Support of audits from authorities, Notified Bodies, and test houses

  • Support of 510K documents and submissions

  • Review and consulting of internal compliance process documents

  • Other customer specific requests in the areas of product safety, EMC, Radio, or Regulatory Affairs

  • Customized training and seminars