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Medical Devices

The medical device regulatory landscape is constantly changing, no matter where you are in the world. On top of that, the market is becoming more complex and more competitive, making every decision a company makes, regardless of size or market share, increasingly more critical. Medical device companies are feeling pressured to complete projects faster with fewer resources and less budget. Covita Health Partners understands these challenges. By keeping patients and compliance at top of mind and leveraging our vast resources and experience, network, and innate creativity, we can help get you where you want to go, when you want to get there.


Our team has successfully guided clients with products in every medical device therapeutic area. From ophthalmology to orthopedics, angioplasty to wound care, we’ve been there before. Our breadth of experience in different sectors enables us to better serve our clients by using those insights to create innovative strategies for success.
We have a deep understanding of the medical device lifecycle and the distinct challenges at each phase. CHP is uniquely positioned to help you navigate these complex issues to stay on budget, stay on the right side of compliance, and accelerate product development and commercialization.


Click on the phases of the medical device lifecycle below to learn more about how we can partner with you at each phase.

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Ideation

At the ideation phase of a medical device, innovators define the clinical need and begin shaping a regulatory and development strategy to guide the path forward.

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Development & Testing

During the development and testing phase, the medical device design is refined, prototypes are built, and verification and validation testing are conducted to ensure the device meets safety, performance, and regulatory requirements.

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Marketing Submission

In the marketing submission phase, the medical device manufacturer compiles and submits the necessary regulatory documentation to obtain market authorization from the appropriate regulatory body.

Commercialization

During the commercialization phase, the medical device is launched into the market, supported by a fully implemented quality management system, compliant labeling, distribution strategies, and postmarket surveillance plans.

Market Growth

In the market growth phase, a medical device gains broader adoption, requiring strategic scaling of manufacturing, supply chain, and regulatory support to maintain compliance while meeting increasing demand.

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