Small Business Solutions

Market access for medical device companies requires complex interplay between commercial, regulatory, technical/clinical, and quality management requirements, all of which must be navigated in parallel to maximize the chance of success in demanding healthcare markets.

Our suite of lean Small Business Market Access Solutions gives medtech startups the tools to:

• Convince investors and funding agencies that they have a viable path to commercialization
• Lay the groundwork for developing safe, effective health technology
• Develop a compelling value proposition

• Regulatory assessments & strategy development (Canada/USA/EU)
• User requirements specification
• Medical device regulatory fundamentals training
• Data privacy requirements for medical devices

• Business case analysis
• Value dossier development
• Preliminary reimbursement assessment (USA)

• Identification of applicable technical standards
• Determination of required testing and certifications
• Technical dossier / Medical Device File development

• QMS essentials
• Risk management
• Software & cybersecurity QMS considerations
• Supplier evaluation and purchasing