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  • info@omcmedical.co.uk
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Services

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Services

Services Offered by OMC Medical

  • Regulatory Country Submission
  • Regulatory Strategy
  • Database Maintenance
  • Regulatory Intelligence
  • Regulatory Training
  • Regulatory staffing-Interim and Permanent
  • Software as a Medical Device(SaMD)
  • UKRP
  • Labelling and Artwork
  • Design to Sale regulatory assistance
  • Global Language Translation
  • Importer Services

World Country

Europe
Asia
Africa
Oceania
South America
North America
Services
Regulatory Country Submission
Consultation on the country requirements globally
Quick registration turnaround times for complex registration globally
New device registration with project management across the globe
Regulatory Statergy
Product change analysis and implementation strategy for your MD
Database Maintenance
Manage all current licenses and trigger the registration process before expiry, keeping all the licenses up to date.
Regulatory Intelligence
Keep you up to date with all regulatory changes across the globe with a minimum subscription fee.
Regulatory staffing-Interim and Permanent
Outsource your regulatory activities to us for a cost effective regulatory solution.
OMC Medical provides you with fully trained experts to assist in your company’s regulatory operations and statergy. We provide services and solutions by applying regulatory knowledge to help you ensure regulatory compliance across the globe.
Software as a Medical Device(SaMD)
Analyze your software classification
Version updates, or changes from a regulatory perspective
UKRP
Act as your United Kingdom Responsible Person (UKRP)
Regulatory Training
OMC Medical provides web-based training to medical device companies. Our consulting helps companies improve their teams’ knowledge of the regulatory requirements, thereby increasing their compliance with regulations, enhancing better project planning, and quick issue resolution.
Labelling and Artwork
Labels as per respective country’s requirement
Global Language Translation
Translation of User Manual, Brochures, Labels, Technical File
Design to Sale regulatory assistance
We assist you right from design and development to analyse the regulatory standards compliance requirements, next to the manufacturing stage, until the post market stage for medical device approval.

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