GRMA is in the process of developing a Medical Device/Consumer Product (MD/CP) Standard. Our goal is to utilize a group of key industry stakeholders that represent the MD/CP sector to develop the standard over the remainder of 2019 and into the first quarter of 2020. Our strategy is to create a standard based on product risk that would encompass consumer goods, making the potential for true global acceptance. The GRMA will then adapt this standard into its array of audit schemes. This process is known as the “protocol method”. This method allows for the rapid development of the standards so they can be brought to market in a timely fashion. Once the standard has been developed, the GRMA will then begin the formal process to become an ANSI Consensus Standard.

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Good Manufacturing Practices for Medical Devices