Since 1999, Fang Consulting, Ltd. has provided Regulatory Affairs, Quality System, and Clinical consulting to a wide range of clients from some of the world’s largest medical device manufacturers to small, start-up organizations. Our team of consultants has expertise in the most current global regulations and certifications and provides both pre-market and post-market support. We are able to assist our clients in finding the most efficient means to achieve their goals within the strict medical device laws and regulations and we proactively advise against or help our customers mitigate impending risks.
Because regulatory authorities hold you to a high standard, you can hold us to a high standard. We know that you want to launch a safe and compliant product into the global market as efficiently as possible.
Let Fang Consulting be your guide through the domestic and international regulatory maze.
EXPERIENCED. THOROUGH. COMPLIANT.
Fang Consulting is headquartered in the midst of Minnesota’s Medical Alley with a widespread, global network of resources and connections. We're lucky to employ incredibly smart, impactful individuals who utilize their experience and advanced educations to serve as trusted partners to help solve our clients' biggest challenges.
Fang's adaptable team affords us the opportunity to provide customized on-site and remote support for our clients. Our clients appreciate the fact that our structure lends itself to short, clear lines of communication which result in high quality deliverables.
We have created a unique work environment in which Principal and Senior Consultants help build the future of medical device experts by mentoring and overseeing the work of our Junior Consultants, resulting in a professional, yet fun culture.
While many of us in the United States (US) think immediately of the Food and Drug Administration (FDA) when regulations are mentioned, our global marketplace demands global compliance with a wide range of agencies and ministries to meet Regulatory, Quality and Clinical requirements. Your Fang team can help you manage the following:
The Fang team has expertise in the most current global regulations and certifications and provides global pre-market submission and post-market support. Let Fang Consulting be your guide through the domestic and international regulatory maze.
Our experienced team knows and understands the ever-changing global quality and compliance requirements and has significant experience creating quality management systems that comply with FDA and ROW regulations. We work with you to customize your quality systems that specifically address your unique needs.
Our “Super CRAs,” with over 80 years of combined experience and who are all licensed professionals in nursing, are able to provide unique clinical support including on-site case support, site training, and CER development and maintenance.
If you are looking for the best path to begin distributing your device, warehousing and shipping solutions and services or if you have questions about how to handle distribution of your product in general, the Fang team has got you covered.