Delivering Regulatory Affairs and Quality Assurance consulting to medical device companies since 1999.
Fang Consulting provides experience and insight to the ever-changing global regulatory, quality and compliance requirements. We bring significant experience to the creation of quality management systems (QMS) to assure full compliance with FDA and ROW regulations.
The Fang team has expertise in current global regulations and certifications, including EU MDR and IVDR. We are your partner for global pre-market submission and post-market support.
We will partner with you to provide the best path to distribute your medical device. We also directly provide fulfillment, shipping solutions and services with all required regulatory documentation.