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Our Services
We deliver customized expertise across a broad range of therapeutic areas — helping guide your MedTech product from concept through commercialization.
What We Can Help You With
Reference regulator certification is the key to unlock some of the largest jurisdictions for medical devices. We will build a regulatory strategy unique to your technology and guide you through device testing and documentation to ensure maximum clarity during review, shortening your time to market.We will mediate on your behalf during your device conformity assessment by Health Canada, EU Notified Bodies and the FDA and make sure that your business meets all requirements for a smooth fast approval.
Obtain Major Market Approvals
Obtain Major Market Approvals
Multi-market Regulatory
Strategy
Technical Documentation Preparation
eSTAR 510(k)
Q-Sub
RegulatorLiaison
CE Mark Canadian MDL
Post-Market Compliance
Reference regulator certification is the key to unlock some of the largest jurisdictions for medical devices. We will build a regulatory strategy unique to your technology and guide you through device testing and documentation to ensure maximum clarity during review, shortening your time to market.We will mediate on your behalf during your device conformity assessment by Health Canada, EU Notified Bodies and the FDA and make sure that your business meets all requirements for a smooth fast approval.
Obtain Major Market Approvals
Obtain Major Market Approvals
Multi-market Regulatory
Strategy
Technical Documentation Preparation
eSTAR 510(k)
Q-Sub
RegulatorLiaison
CE Mark Canadian MDL
Post-Market Compliance
What Our Clients Say
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Packages
Risk Classification and Regulatory Strategy
Great for companies of all sizes, we provide you with a risk document that contains the rationale and strategy for 1 country or for global commercilization
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