Medical Device Control Document Medical Device Control Department Department of Health, Malaysian gd-xx Guide on Medical Device Classification The guide invites homeowners to check and approve most changes before they are implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the trend letter “3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.” While it is important to secure long-term care and maintain the current configuration of a component crucial to the design of your medical device, the process can become a little more complex. Typical components that can be checked are those that are exclusively intended for the performance or safety of your medical device. A supplier quality contract or delivery contract may be required. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. At a minimum, a quality agreement should define the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: when a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change.
With just a few months to go before the full implementation of the 2017/745 Medical Devices Regulation (MDR), the time has come for the positive aspects: the MDR contains constructive guidance on many crucial aspects, including the definition of contractual agreements between partner economic operators in the design and manufacture of devices. This article highlights the issue of quality assurance agreements between manufacturers and their first OEMs (equipment manufacturers). An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site.