Supporting All Aspects of Medical Device Development and Production

Process Development

* Coordinate and lead the creation of product development processes compliant with the appropriate standards and regulations.

* Compliance evaluation - gap analysis of procedures and processes.

* Development of the capacity to certify products (apply safety marks) in-house.

Device Compliance:

* Device Standard / Design Gap Analyses

* Identification of Applicable Standards

* Equivalent Safety Analyses

* Interface with Certification Bodies

Liability:

* Independent product safety evaluations

* Establishment of "state of the art" for safety of specific products

* Support during discovery

* Expert witness

Licensing and Acquisitions:

* Due diligence audits (products and organizations)

* Market opportunity evaluations

Developing new markets:

Evaluation of new foreign markets and entry strategies to penetrate them

· Identification of regulatory requirements and approval strategies

· Identification of local partners/representatives

· Development of customer profiles

· Coordination of strategic execution of your plans

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