In Vitro Diagnostics Support Provided

The Kymanox IVD Medical Device team can assist you in evaluating your quality system to seamlessly achieve compliance with global design control and risk management requirements, saving you from costly delays and deviations.

Competitive Landscape and Technology Feasibility Assessments

Let us do the legwork of finding the appropriate predicate device and evaluating competitor products to guide your development effort. We can support any stage of the product life cycle, whether you have a concept or an already defined technology. We have specialists in assays, engineering, and production who can dig into the weeds for all aspects of your product.

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Regulatory Strategies

We work with your team to understand your unique product and tailor a regulatory strategy that addresses the requirements of your target market(s). As part of this customized strategy, we will prepare a Regulatory Plan that lays out the timeline and framework for interactions with regulatory bodies. Our team can also facilitate those interactions, whether that means to prepare your team in the background or serve as your point of contact.

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Tailored Technical Documentation

We work with your team to prepare the appropriate technical documentation based on your unique product and where it is in the development process. We are experts in implementing Design Controls and preparation of the Design History Files and Technical Files necessary to support regulatory submissions in the US and the rest of the world. Involving Kymanox early can prevent costly back-tracking and retrospective documentation that often cause costly delays.

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Risk Management

We work with your team to adapt and apply elements of ISO 14971 and the new In Vitro Diagnostic Regulations (IVDR) to your unique device. We remain up-to-date with the current standards and regulatory guidance to ensure your product maintains compliance throughout the development lifecycle.

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Clinical Evidence

We work with your team to define the clinical performance for your unique product. We have Clinical specialists who can conduct clinical evaluations and manage post-marketing clinical follow-up for your device, ensuring compliance and efficacy with regulatory standards and guidances.

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Supplier Management

We audit and manage your suppliers and establish seamless processes that integrate with your quality system.

  • • Supplier Selection, Auditing, and Management
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