Boulder iQ offers a wide range of services to help you meet federal and international requirements.

Our services help you to get your products to market more quickly– and maintain your FDA compliance status.

 

 

With years of experience in the healthcare industry, Boulder iQ has helped hundreds of companies obtain FDA clearance and CE marking. Boulder iQ will work with you to make sure your product meets all regulatory, quality and clinical compliance regulations, both domestically and internationally.

Looking for funding? We’ll help you minimize regulatory and compliance risk to attract early-stage investors.

We can provide guidance on every aspect of global medical device clinical regulations (ISO 13485:2016 certification through Boulder BioMed), and offer full regulatory and quality affairs on an outsourcing basis.

FDA Consulting and Services

 

  • Classification
  • Pre-sub (Q-Sub)
  • Device registration and listing
  • Submissions
    • 510(k)
    • Digital health
    • Medical device design and research studies
    • Process and software validation

FDA Consulting and Services

 

  • Product verification and validation procedures
  • Software Security and Validation
  • Implementation
  • Compliance for start-up companies
  • Corrective Action/Preventive Action (CAPA)
  • Remediation
  • Audits
    • ISO 13485
    • FDA QSR
    • MDSAP
    • Internal
    • Gap Analysis
    • Supplier
    • Clinical research study

European Regulation Consulting and Services

 

  • EU technical documentation for the MDR
  • Clinical Evaluation Reports (CER)
  • CE Mark approval processing
  • Post-Market Clinical Follow-up (PMCF) studies and reports
  • Post-Market Surveillance (PMS)