Clinical Affairs Consulting for the Medical Device Industry 

You have a well-designed medical device, or perhaps just an early idea or prototype, with a solid value proposition, but do you have the clinical evidence strategy to unlock its full commercial potential?

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• Regulatory Approval: Ensure you have the evidence needed to meet regulatory requirements.

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• Market Access: Provide the necessary evidence to satisfy public and private payors across all target markets.

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• Clinical Impact: Create compelling evidence that resonates with clinicians and patients alike.

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The Challenge: While achieving regulatory clearance is a significant milestone, the greater challenge often lies in convincing payors to make your product made available to those who need it. By integrating these considerations into your early-stage plans, you can maximise the value of your clinical work.

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How we can help: At Evistrat Consulting we specialize in crafting strategic clinical evidence plans tailored to your specific needs. Working closely with you, and leveraging our experience of EU MDR and FDA requirements, we will develop a robust strategy aligned with your commercial goals . 

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We also provide expert support in planning to ensure readiness for clinical trials. Our clinical affairs perspective adds value to cross-functional team activities such as project planning and business case reviews.

 

If you are interested in how we can help please use the contact form to get in touch.