Isoplan is a medical device consulting firm with offices in USA and Europe, which offers the following FDA consulting services:
- FDA Registration and Medical Device Listing
- FDA Clearance Consulting for Medical Devices
- US FDA Agent for Medical Device Companies
- FDA Regulatory Consulting
- FDA Quality System Compliance
Whether your company is a startup or a multinational firm, we understand your challenges and deadlines, and can help you meet the requirements for FDA marketing clearance in the United States.
Our professional medical device and IVD (In Vitro Diagnostics) consultants operate with integrity and purpose and treat each project in a tailored fashion to help you achieve FDA compliance quickly and cost effectively.
Isoplan was established in 2004 by Ing. Enrico Bisson, who has worked several years for a multinational firm specialized in International medical certifications with offices in Europe, USA, Japan and China. Our FDA medical device consultants are professionals specialized in medical, technical, scientific and legal fields and can effectively assist you in FDA regulatory, FDA clinical study and FDA quality system strategies to reduce costs and time to market.
If your company is located outside the USA, Isoplan USA can serve as your United States FDA Agent and act as a liaison between your company and the FDA.
1368 North US 1 – Suite 402
Ormond Beach, FL 32174 – USA
ISOplan Europe (Headquarters)
Via Marzia 9
35031 Abano Terme (PD) – Italy
67 Maari Road
6023 Duncraig, Western Australia – Australia
Phone: +61 040-6109100