An International Marketplace with the Largest Online Business Directory of Buyers & Sellers.

Medical & Dental Devices - Regulations


Company Profile	Products	Contact Us

Company Profile

Medical Devices & Biosciences Int'l is a regulatory affairs consulting company. We work with medical or dental device companies who wish to expand and enter North America's market. We provide the regulatory compliance and consulting services for those device companies.

The medical & dental device regulation process for North America's market is designed to make sure the device is safe for the patient and does what it was intended to do. The information specified by the Medical Devices Regulations is reviewed by doctors, scientists, and engineers. If the information is approved by the government agency you will be notified in writing allowing you to legally sell the device. On occasions, more information is required to clarify information.

The information required by the regulations can range from 30 to 50-page report. On the average the approval time can take from 60 to 120 days and is dependant on the information available or missing. Consequently, a quick turn around time of information is preferred to get an early approval. Since, there is a cost for getting devices approved, companies should make sure, the sales opportunities justify the expenses. Once the parties have decided to move forward, an agreement is mutually prepared and signed outlining the regulatory work required.

Business Type :

Others

Year Established :

2005

Main Markets :

North America

Annual Sales :

Below US$1 Million

Products

Medical & Dental Devices

All Medical Devices and Dental Devices must comply with the Medical devices Regulations. The regulations provide all the necessary guidance to get
more details...

Roger
1590 Oakburn St.
Pickering
Ontario
Canada
Phone: 1-905-5098543
Fax:

Medical & Dental Devices - Regulations

About Tradeget

Buying on Tradeget

Selling on Tradeget

Support & Help