Omsbar Medical Device Design Manufacturing and Regulatory Services



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Training
Omsbar provides training courses on or off-site, tailored to your requirements. Presentations range from overview level to one-on-one sessions on a specific topic. Training can be about theoretical requirements or site-specific problem solving. Workable solutions will result from such training, normally associated with a period of on-site assessment and auditing before and after the course.

 Training courses available include:
  The Medical Device Directive and the CE Marking Process
  Technical File, Design Dossier and 510k Requirements and Construction
  Other European Directives (WEE, EMC etc)
  ISO9001 and ISO13485
  The USA Code of Federal Regulations and the 510(k) process
  Labels and Labelling of Medical Devices for Global Markets
  Hazard Analysis and Risk Assessment for Global Markets
  Biocompatibility and Chemical Compatibility Testing for Global Markets
  Design Control for Global Markets
  Software Design, Verification and Validation for Global markets
  Auditing, Complaints Handling and Service and Maintenance for Global Markets
  Manufacturing Process Control and Traceability
  Calibration, Equipment Control and Statistical Methods for Manufacturing
  Electro-Static Discharge Control for Manufacturing
  Cleanroom Control and Maintenance
  IEC60601 - Requirements of the Standards and how to satisfy them
  ISO10993 - Requirements of the Standards and how to satisfy them
  Sterilisation Validation
Additional training courses can be assembled and tailored to specific requirements. Full course materials and notes are provided as part of the training package.