Quality Agreement Medical Device Template

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.” 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. A quality agreement should at least specify the obligations and responsibilities of each party in the following basic elements, as outlined in the guidelines: Note: The supplier`s name and the customer`s name may be supplemented by other descriptive information about the company such as Company X, a contract manufacturer of medical devices duly organized and existing according to company laws. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. The FDA does not have a specific policy for quality agreements between medical device companies and CMOs that provide them with services. However, FDA guidelines state that quality agreements should cover activities under Category 21 CFR Part 820, the Quality Assurance Regulation (QSR) for medical device companies, “if applicable.” Given the inclusion of Part 820 in the guidelines, a quality agreement between a medical technology company and an CMO should take into account, to varying degrees, the following aspects, depending on the nature of the relationship between the two parties and the products and services concerned: the pace of innovation and competition in the life sciences are relentless.

It encourages a growing number of companies to adopt asset-light operating models, which rely heavily on an ecosystem of labour-producing organizations (CMOs). As a result of this trend, the burden of implementing the current Good Manufacturing Practices Directives (PMCs) is increasingly being shared between the companies that own the products and the contractual bodies on which they depend. A strong quality agreement is the first step in ensuring that both parties are accountable and cooperating to comply with the rules imposed by the U.S. Food and Drug Administration (FDA). 7 QMS quality repair management action system on non-compliant hardware in order to make acceptable as the planned use of post-processing action on non-compliant equipment, in order to meet the requirements of RMS risk management scrap system action on hardware not compliant with its originally intended supplier use The supplier provides product to the customer. The term supplier includes, under its guidance, contractors, consultants, sister organizations and higher organizations. Reference Papers 21 CFR Part 820 Quality SystemVerordnung GHTF/SG3/N15R8 Implementation of Risk Management Principles and Activities within a GHTF/SG3/N Quality Management System17:2008 Quality Management System Medical Devices Guide for Control of Products and Services Provided by Suppliers iso 9001:2008 Quality Systems Quality Requirements For Medical Devices Presentation Page 5 of 17. In the eyes of the FDA, any activity that is not documented may as well not have occurred.