CONSULTING

Looking to develop your medical product but not sure where to turn? Need help planning or executing your next medical device project? Let us guide you with Consulting services. Any organization can develop with small incremental changes, but building for the future in today’s rapidly evolving business environment means taking bold chances and making insightful decisions.

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Some of the areas we specialize in include:

• Market research and voice of customer supported development of user needs, design requirements and product specifications.

• Leverage additive manufacturing technologies for supporting design and development, from rapid prototyping through clinical builds.

• Materials identification and selection with a focus on sterilization and design for manufacturing requirements.

• Developing fit-for-purpose preclinical plans with evidence generation packages that are appropriately scaled for 510(k), De Novo, PMA and IND submissions, including external vendor management.

• Developing bespoke in-vitro, small and large animal preclinical models that truly challenge your device.

• Using computational simulation and modeling to augment your evidence generation strategy.

• Developing combination products with an eye toward the specific regulatory requirements of both CDRH and CDER.