• Medical device design, build, verification and validation services
  • In-house prototyping and small-scale production facilities
  • Medical regulatory affairs – including USA, EU and global registrations
  • Quality assurance services – extensive medical device expertise
  • IEC60601 compliant power supplies and isolators

Welcome to Omsbaromsbar 3x squares icon

  • We have ISO13485 accreditation and provide contracted medical device design, development, regulatory, validation and manufacturing services
  • We provide these services using our own in-house team and facilities
  • We are an engineering organisation, enabling us to provide a fast and responsive service to satisfy your product design,  manufacturing, validation and compliance issues
  • We have a range of IEC60601 compliant power supplies, battery supplies and signal isolators/converters  to solve difficult power sourcing issues and legacy equipment

All images on this site originate from Omsbar - we do not use stock images

Technical servicesomsbar 3 squares icon

  • Product design and development
  • Usability
  • Risk analysis
  • Prototyping
  • Small-scale manufacture
  • Verification and validation
  • Client product handling and logistics
  • Medical device clinical trial construction

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Resourcesomsbar 3 squares icon

13485 and 9001 accredited facilities including:
  • Clean room and clean manufacturing
  • Microbiology and sterilisation
  • Environmental chambers
  • Mechanical workshop
  • Electronics workshop
  • Software development and testing
  • Client QMS document archiving

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Compliance servicesomsbar 3 squares icon

  • Technical files and design dossiers
  • 510k’s
  • 62304 and 62366 compliance
  • MedDev and standards compliance
  • Global registrations and manufacturing
  • Contract QA/RA management
  • Feasibility studies

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Productsomsbar 3 squares icon

60601 compliant OEMs including:
  • PC power supplies
  • Bespoke power supplies
  • Battery powered and back-up power supplies
  • Signal isolators/converters and wireless linkers for legacy equipment

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