SERVICES

Our Services

Whether your company is just entering the medical device market or you’re an established business in need
of regulatory advice, our team knows what it takes to achieve your business goals.

Our Capabilities

PLANNING

  • Regulatory Planning
  • Clinical Research Planning
  • Entry into US market
  • Interpretation of standards and guidelines
  • DHF analysis and remediation
  • Standard Operating Procedures
  • DHF analysis and remediation
  • QMS preparation for 21 CFR 820,
    ISO 13485, and EU Medical Device Regulation

STRATEGY

  • Preclinical Strategy
  • Cybersecurity
  • Quality Management Systems Support
  • Labeling
  • Unique Device Identification
  • Risk Evaluations
  • Post-market surveillance and PMCF
  • FDA Inspections Remediation Support

RESULTS

  • 510(k)
  • De Novo
  • Clinical Evaluation Reports
  • CE Marking
  • International Device Registrations
  • Investigational Device Exemption
  • Medical device reporting (MDR) and
    complaint handling
  • Management Systems
  • Technical Files

LET’S GET STARTED!

Reach out for more information on consulting services or to schedule a consultation.

Contact our team