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

Full range of domestic and international regulatory services

Domestic

Audits: FDA QSR, pre-certification, pre-inspection, supplier, clinical research study
Regulatory strategy development
FDA Pre-Submission, Q-Submission, meeting coordination
513(g): Request for Classification
FDA submissions: 510(k), IDE, PMA, De Novo
Clinical Evaluation Reports, technical documentation, Declaration of Conformity
Remediation activities (including 483 observations, warning letters, recalls)
Post-market surveillance

International (Europe, Canada, Japan, Australia, South America)

Audits: MDSAP, pre-certification, pre-inspection, supplier, clinical research study
Regulatory strategy development
EU MDR, IVDR: complete transition planning and execution
CE mark submission
Clinical Evaluation Reports, technical documentation, Declaration of Conformity
Remediation activities (including audit findings, recalls)
Post-market surveillance
U.S. agent for foreign manufacturers

Internal

Audits: Internal, pre-certification, pre-inspection, supplier, clinical research study
Regulatory strategy development
Compliance and/or remediation activities

Quality Assurance

Comprehensive support to assure safe, effective devices through their lifecycles

Audits: quality system, ISO 13485, internal, gap, supplier, clinical research study
ISO 13485-compliant quality management systems: evaluation, development, implementation
- Gap assessment
- Evaluation of their current system to define scope, document transfer needs
- eQMS system recommendations and implementations
- Transfer of appropriate QMS documentation
- Recommendations for ongoing activity
Software security and validation
Corrective Action/Preventive Action (CAPA)
Remediation activities (including audit findings, recalls)
Compliance for start-up companies

Clinical Trial Strategy and Planning

In-depth expertise to demonstrate device efficacy and safety

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)