Developing a medical device is hard work. It’s important to protect your time and efforts by developing a regulatory strategy that will allow you to begin marketing and selling your device quickly. I can help you build a regulatory strategy for the US, Europe and other markets.
Fumbling a 483 or Warning Letter Response or mismanaging a recall or MDR can be an extremely costly misstep. The greatest compliment clients give me is that they should have called sooner. I can help your company respond and protect its customers and its brand.
My practice is among the few in the US to focus on food law issues. Colleagues in the food industry cite me as being “to the top of the field in supporting food producers” with an “outstanding knowledge of the intent, context and substance of the newly enacted Food Safety Modernization Act.“
Consulting & Contract In-House Services
Food Law and Medical Device Compliance
All aspects of working with the FDA and USDA/APHIS ( for example: 483 Inspection, 483 Response, Warning Letter Response, Updating SOPs, Complying with QSR, Compliance with 21 CFR (medical device, food packaging, food processing regulations), Letters of Assurance, Letters of Guaranty, Managing Recalls, 510(k), Special 510(k), CLIA).
Ranging between $100 to $300/hr depending on complexity, interaction with FDA/USDA etc. Contact me for a free consultation.
Letters of Assurance/Guaranty Flat Rate Package $2,500
510(k) and Special 510(k) Flat Rate Available (flat rate varies based on complexity of device, clinical trials, etc.)
Recalls with Consumer Product Safety Commision
Preparing for recalls and managing active recalls initiated by the Product Safety Commission
Starting at $200/hr
Updating employee manuals to accomodate changes by the NLRB and the use of new technology. Also, defense of employee privacy complaints originating under federal law (Stored Communications Act and National Labor Relations Act).
Starting at $200
Social Media Training
From the basics of using social media to LinkedIn search optimization, social media strategy, social media skills (HR, marketing,) and reputation management (ethics and legal issues).
Starting at $1,500 for hour long session and training materials (on-site in the Atlanta metro area).