Our Offerings

Regulatory requirements impact your products – and your business – throughout their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between your financial success and misfortune. Our regulatory FDA device clearance consulting professionals work with you to develop and execute a roadmap to commercialization by ensuring you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. Our FDA device clearance consulting experience covers regulatory requirements of the US, Canada and Europe.

• Regulatory Roadmaps
  • Strategy for US commercialization with FDA 510(k), PMA and de novo
  • Strategy for EU and Canadian commercialization with CE Marking
• Regulatory Gap Analyses
• Regulatory Compliance Initiatives
  • GxPs, 21 CFR Part 11 and Annex 11
  • European Directives and CE Marking
  • FDA Submissions to Obtain FDA Clearance
  • Medical Device Technology and Software Validation
  • Human Factors Validation
  • HIPAA
  • Representation before Regulatory Bodies
• Submission Support:
  • Document Preparation
  • Guidance for Pre-Submission Meetings
  • Risk Assessment and Remediation Strategies
  • Submission Changes
• Quality and Product Certifications
  • IEC 60601-1 3rd Edition Amendment 1 Safety Testing Documentation Preparation
  • ISO 14971: 2012 Compliance and Documentation Preparation
  • IEC 62304 Software Development Lifecycle Compliance
  • ISO 13485 Compliance and Documentation Preparation
  • Test Laboratory Document Submission
• Auditing Services
  • Internal Audits and Compliance Remediation
  • External Audits and Vendor Management Compliance