Consultants fill the gaps in firms that have limited staff or wish to enter the industry and have no idea where to start with compliance. In my experience, the fact stands that FDA holds everyone in the supply chain of making a medical device accountable. Even if you supply only a specialty component or service to a medical device firm, it is important to assure your link in the chain is firmly secured.

I feel that there are overabundances of consultants in this industry that do not adequately address the needs of the small business. For example, I have heard numerous horror stories about consultants that provide boiler plate procedures and Quality Policy Manuals and simply leave the company to try and adapt these procedures to their operations. You go to a consultant for their expertise and counsel. You don’t spend your company’s hard-earned money to pay for procedures that you could have bought online for $200.

All of my working life, I have worked for small to medium sized firms. With the exception of one who had Regulatory staff, all have been ripped off by the bad advice of a consultant and in some cases have been made to pay for that bad advice with a bad reputation with FDA.

My philosophy is that such counsel at a reasonable price, giving the same attention to detail and receptiveness to every customer’s individual needs as well as or better than a high-powered consulting firm. I want to be part of your team and see you be successful in your endeavors. I will teach you how to create and nurture an environment for a transition to this industry long after my work is done.