A supply contract is a contract for the sale of goods from one party, the supplier, to another, the buyer. Often, some of the essential terms are missing from the agreement, which can lead to problems for both parties. A supplier agreement focuses more on liability and logistics issues, including the following: Design Controls: When creating a Class II or III medical device, you must comply with FDA design control requirements and document all related procedures and activities in your quality agreement. This ensures that your product is developed and designed with certain safety measures in mind. A quality agreement ensures that you and your material supplier or contracted manufacturer are on the same page by laying the foundation for quality and communication standards. It plays a crucial role in avoiding fines, which can amount to tens of millions of dollars for some medical device companies, and in providing the best possible product. Remember, even if the FDA doesn`t require a quality agreement, it shows them that you take quality seriously. Insisting on a quality agreement from the beginning also signals to your potential partners that you prioritize quality and that your business is likely to be efficient and more likely to make a profit. In summary, quality assurance agreements are not only the expected control method for high-risk suppliers, but can also provide clearer and smoother processes for both the manufacturer and the supplier. Once both parties are satisfied with the agreement, ask your legal team to conduct a full review. Your legal team will review the agreement and ensure that all the necessary legal wording is in place and that the agreement meets the organization`s requirements. Regulatory requirements that your device must meet: If your device requires approval from a specific governing body if it is present in many markets, your agreement should describe this process.
The approval of the equipment depends on whether your partner follows the guidelines of the governing body, so this section is especially important. Do suppliers or OEMs welcome such in-depth agreements? Scott says there is less resistance from companies that make critical components for a particular company. But when it comes to companies that buy ready-made products to make medical products that make up a small portion of their overall business, there are more headwinds. The supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practices) obligations of the design owner and supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including on-demand audits) or understanding of the supplier, its processes and capabilities. A quality contract must not contain commercial or liability clauses that should be dealt with exclusively in a supply contract. Your supplier agreement or any related procedure or work instruction must clearly indicate which suppliers must have quality assurance agreements and which ones must be taken into account for these agreements. The procedure should also determine the content of quality assurance agreements and who is responsible for creating, approving and amending such agreements. At a minimum, quality and related services (usually operations or manufacturing) should approve these agreements. The number of approvers should be kept as low as possible so that agreements can remain flexible enough to be kept up to date according to experience and events.
Although your process should define the areas that should be covered by a quality assurance agreement with a supplier, quality assurance agreements should always be developed jointly between you and the supplier. Neither side should take anything for granted. These agreements are a working tool to help you and the supplier understand your roles and responsibilities and promote good communication between the two of you. The manufacturer must agree with the supplier on individual responsibilities and services. While you, the manufacturer, are ultimately responsible for the medical device, the supplier also has certain obligations. Supply Chain Agreements. Companies face a variety of agreements in the development, manufacture and distribution of their products. Many of these agreements include joint ventures, production or demand contracts, take or pay financing agreements, equipment leasing or franchising. Distributors should have quality assurance agreements because they are directly linked to the customer and the extent of their responsibilities can have both qualitative and regulatory implications. For example, if action on the ground is required, it is important that a distributor is cooperative and has the necessary information. In addition, equipment that requires installation and/or maintenance and is often the responsibility of a dealer can seriously affect both the safety and operation of a device.
Outsourced processes are in turn a part of the manufacturing process that you, as a manufacturer, do not control directly. There are often processes that you can`t easily verify that they worked properly. In addition to process validation, quality assurance agreements are a way to maintain control over outsourced processes. As required by these guidelines, risk should be taken into account when deciding on the type of control for suppliers. High-risk suppliers and outsourced high-risk processes such as sterilization and contract design and development are examples of processes that are generally considered key or critical and should therefore be subject to quality agreements. This medical device supply agreement is an agreement that allows the buyer to purchase certain products intended for use in the manufacture of its own medical devices. .
