Regulatory Services

OMEDtech works with US companies wanting to enter the international market via CE marking as well as International companies seeking to market in the US via FDA clearance/approval.  We help you determine your product’s classification and identify predicate devices to support your classification and develop a successful regulatory pathway to market approval.  We assist you with your communication with both FDA and the EU notified bodies during classification determination, meetings with FDA or Notified Bodies.  We provide analysis, response and resolution to compliance findings associated with submissions, inspections and audits.

Regulatory Submissions

OMEDtech has a great deal of experience in developing regulatory strategy and submitting regulatory submissions.

  • 510K Notifications
  • CE Marking, Technical Dossiers, STED
  • IDE/HDE submissions
  • PMA Applications
  • 513g Request for Classification
  • Canadian Licensing
  • Combination products
  • Software as a medical device
  • In-vitro diagnostics

Regulatory and Compliance Consulting

  • Regulatory Strategy for successful marketing submissions EU CE mark and FDA.
  • ISO 14971 Medical Device Risk Management
  • Medical Device Validation
  • Warning letter and/or form 483 response and resolution
  • Regulatory affairs outsourcing
  • Audit and inspection support
  • CAPA and complaint remediation
  • Identify and correct regulatory deficiencies,
  • On-site assistance with audits and inspections
  • Assistance with complaint review, MDRs and Vigilance reports
  • Corrective action responses
  • FDA establishment registrations
  • FDA medical device listings

Due Diligence Audits

OMEDtech provides due diligence audits that ensures the company being considered has a quality system that maintains regulatory compliance of products in the countries were they are marketed.

US Agent

US Agent:  OMEDtech can provide US agent services for companies based outside the US as required by FDA regulations.

Clinical Trials

OMEDtech provides medical device clinical study services which include:

  • Pre- submission (pre IDE) consulting and planning
  • Small size clinical trial design
  • Clinical study development
  • Implementation of clinical trials
  • Clinical study management and monitoring services