If you are an innovator and growth company leader operating in the medical device and diagnostics industry, you know how challenging it is to navigate one of the most risk-sensitive and complex business terrains.
Heavily regulated by the federal government and highly scrutinized by the public, advocacy and watchdog organizations, device companies face intense pressure on a number of fronts as they bring their products to market and compete to achieve competitive success for their stakeholders.
FGD team members, led by Founding Partner Karin A. Gregory, have extensive experience across the business lifecycle of device and medical technology manufacturers. We provide expert guidance in achieving commercialization of your products – particularly in the key areas of regulatory affairs, reimbursement and financing. Our team has also successfully representing clients involved with medical board licensing issues around FDA compliance in addition to employment regulations.
We are prepared to guide you in the effective response and management of any number of key operating issues, including:
- Assuring HIPPA compliance
- Understanding new, and anticipating emerging, FDA rulings – such as for mobile applications
- Licensing and protecting your trade secrets
- Dealing with non-compete issues and division of property
- Managing joint ventures
- Developing data security strategies
With the FGD Team, you don’t need a Washington, DC-based firm to manage your federal regulatory affairs. Nevertheless, we have relationships with FDA and other specialists who will partner with us on your behalf if a situation warrants additional feet on the ground within the beltway.
How May We Help? NextStep@fgd-law.com