Regulatory Affairs and Quality Assurance

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.


From completing a short-term project to serving as an outsourced department, Boulder iQ provides the support you need to get your product to market and make sure it stays on the market

regulatory affairs support

Regulatory Affairs Support

  • EU MDR and IVDR: Complete transition planning and execution
  • FDA submissions: 510(k), IDE, PMA, De Novo
  • FDA pre-submissions
  • CE mark submission
  • Regulatory strategy development
  • Clinical Evaluation Reports, technical documentation, Declaration of Conformity
  • Post-market surveillance
  • Remediation activities
  • 513(g): Request for Classification
  • Audits: Internal, FDA QSR, MDSAP, pre-certification, pre-inspection, supplier, clinical research study
  • U.S. agent for foreign manufacturers

quality assurance support

Quality Assurance Support

  • Development and implementation of ISO 13485-compliant Quality Management Systems
  • Process verification and validation
  • Software security and validation
  • Audits: Quality system, ISO 13485, internal, gap, supplier, clinical research study
  • Compliance for start-up companies
  • Corrective Action/Preventive Action (CAPA)

clinical trial support

Clinical Trial Support

  • Strategy
  • Management
  • Planning
  • Protocol development
  • Post-trial support
  • International applications
  • Coordination with notified bodies, competent authorities, principal investigators, internal review boards, ethics committees

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

Regulatory and Quality Consulting 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)