FDA AND ISO STANDARD FOR MEDICAL DEVICES UKAF

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As stated in this new revision of the guidance document, “FDA has identified specific materials in the final finished devices that are included in the policy outlined in this attachment when they are in contact with only intact skin surfaces. The materials can include other processing chemicals and additives (e.g., plasticizers, fillers, color additives, cleaning…

Description

A manufacturer that is certified to ISO 13485 does not inherently fulfill the FDA regulatory requirements. However, this certification aligns the company management systems with requirements of the FDA’s QSR and international regulatory requirements. As such, 13485 provides a management system that serves as a framework for compliance to various regulatory and customer requirements.

ISO 13485 certification also does not fulfill the requirements of ISO 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers. Benefits can be reaped from being both 9001 and 13485 certified, because 9001 focuses on business aspects not found in 13485 that are good for all businesses. Also, ISO 13485 is no longer thought of as pertaining solely to finished medical device manufacturers. Many manufacturers are requiring their sub-tier suppliers to attain ISO 13485 certification as well.