Case Study 41: Regulatory support for QMS Set Up for US-FDA.

Company Situation

The Client is a medical device company that is planning to get ISO 13485 certification in January 2018. The company designs, manufactures, sales, and services its imaging devices that are classified as class 2 in US. The client was looking to set up the quality management system (QMS). They wanted GRP to write the applicable SOPs and quality manual and provide training to their team on it as well.

GRP Solution

GRP brings decades of experience in writing SOPs for companies all across the globe. GRP’s presence in USA and successful track record of obtaining 100% approval for diverse SOPs enabled Client to select GRP as partner of choice for writing of the SOPs for ISO 13485.

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United States of America FDA

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FDA Substantial Equivalence Predicate Device

White Paper : How fda defines subequivalence to predicate devices

The concept of substantial equivalence of medical devices was introduced by the US Food and Drug Administration (FDA) as part of the Medical Devices Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) enacted on May 28, 1976.