ISO 13485 Medical Devices Standards Compliance a "Business Critical Issue" for Manufacturers and Patients Alike

The ISO 13485 Medical Devices standard, like other "ISO Standards" set by the International Standards Organization ("ISO") is a set of manufacturing standards and procedures guidelines that assure quality in the manufacturing and service industries - in this instance, in the manufacturing of medical implements and devices. Working with an ISO 13485 Medical Devices standards consultant is a business critical issue for companies and entrepeneurs entering or engaged in the manufacture and provision of medical devices.

While ISO standards were initially used almost strictly by large companies, increasingly companies large and small have to ensure that they are in compliance with ISO standards and procedures if they wish to bid on contracts, sell their wares or - heaven forbid - defend themselves against product liability suits.

In perhaps no other sector is ensuring ISO compliance more essential than in the manufacture of medical devices for the health services sector. While the quality of the manufacturing procedures and processes behind the production of engine parts for the ambulance that brings a patient to the hospital are unlikely to come into question and turn out to be business critical - although they will be, if the part manufacturer wishes to sell auto parts to Volvo, Mercedes, or whomever the ambulance manufacturer is - compliance with the ISO 13485 Medical Devices standard will be critical for a supplier who wishes to stock that ambulance with the monitors, drips and guerney which will ensure the patient arrives, and arrives safely, at the hospital. (Rule Number One in the medical profession is still, "Do no harm!")

Manufacturers and distributors of medical devices, if acting with prudence, will ensure that they are working with an ISO consultant who is fully versed and has a depth of experience setting up and ensuring ISO 13485 Medical Devices standards compliance. In the health services and medical professions ISO compliance is a business critical issue for all involved - particularly the patient!