Services
Medical-Device Regulatory and Quality Support
Practical support for medical-device manufacturers, importers, and distributors—from defining a regulatory pathway to preparing submissions, developing quality systems, and supporting ongoing operations. Each engagement has an agreed scope, deliverables, and responsibilities.
01
Regulatory Strategy and Submission Support
Clarify the applicable medical-device requirements and develop a practical plan for market access and regulatory activities.
- Medical-device classification and regulatory pathway assessments
- Intended-use and claims review
- Documentation and evidence gap assessments
- Submission planning, preparation, and responses to regulatory questions
02
FDA 510(k) Support
Support the planning and preparation of FDA 510(k) submissions through structured review of device information and supporting evidence.
- Predicate research and substantial equivalence strategy
- eSTAR submission preparation and document coordination
- Review of supporting bench, software, cybersecurity, usability, and clinical documentation
- Support for responses to FDA requests for additional information
03
Canadian Licensing and MDEL Support
Help manufacturers, importers, and distributors understand and address Canadian medical-device licensing and establishment requirements.
- Medical Device Licence application and amendment support
- Medical Device Establishment Licence application and maintenance support
- Importer and distributor procedures and quality agreements
- Health Canada inspection preparation and response support
04
Quality Systems and Inspection Readiness
Develop and improve quality-system documentation and practices suited to the organization's activities and applicable medical-device requirements.
- Quality-system gap assessments and implementation planning
- Procedures, work instructions, forms, and records
- Internal audits, corrective actions, and supplier-quality support
- Preparation for regulatory inspections and certification audits
05
Fractional RAQA Leadership
Provide ongoing regulatory affairs and quality assurance leadership on a part-time or project basis.
- Regulatory and quality priorities, planning, and oversight
- Coordination of internal teams and external service providers
- Review of quality issues, changes, and regulatory obligations
- Ongoing advisory support and implementation follow-through
Ready to discuss your project?
Engagements are tailored to the device, target market, business activities, and available evidence. Scope and deliverables are agreed before work begins.