Why Choose Us

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard. Wecan proudly and safely state that PROMED products are built with quality and transparency in mind to provide products that meet or exceed the needs and expectations of our customers, and always complying with the specifications and regulations. 

The Medical Device Single Audit Program (MDSAP) is a harmonized approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale that will cover and their respective regulatory requirements. The current program participants include: USA, Canada, Australia, Japan and Brazil.

THE MEDICAL DEVICES DIRECTIVE, CE MARKING FOR EUROPE

Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC. PROMED has acquired this certification and our products are eligible to be marketed in Europe.

This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. PROMED products are cleared under FDA 510(k) requirement and are also qualified and marketable in the United States.