Our Mission

Hack & Associates focuses specifically on medical device consultation and strategy for clients within the life sciences sector.  We aim:

To provide cost-effective and efficient risk management mapping, product positioning strategies, due diligence, and market analysis for FDA regulated medical devices.

To provide accurate valuation of medical devices and medical device portfolios both with regard to potential regulatory pathways and intellectual property protection.

To provide clients with FDA regulatory filing support including 510(k)s, IDEs, PMAs.