Karabin adds that the supplier agreement should also describe who is responsible for the device and the design once it is on site. In one case, “we found out that we were responsible for our product, but we were in an unfair position because we didn`t know who the product was being sold to. Therefore, the agreement should include traceability and include details, for example. B who receives the product. Companies need to have more clarity and understanding of how their product is used in the marketplace and, more importantly, how it is misused. “The further away you are from the customer, the harder it is to understand,” says Scott. Supplier agreements can therefore help define the ultimate responsibility for design. If the FDA finds a contract manufacturer who plays a supporting role, who is responsible for it in the field, that creates a difficult compliance situation. The supplier quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and good manufacturing obligations (GMP) of the design owner and supplier. A quality agreement is an essential part of a supplier qualification program, but it does not replace the supplier`s qualification processes (including audits when needed) or the supplier`s understanding of its processes and skills. A quality agreement must not include trade or liability conditions that should be dealt with exclusively in a supply contract.
8 Created by Ombu Enterprises, LLC.ISO 13485:2003 Medical Devices Quality Management Systems Requirements for Regulatory Purposes ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices Products and Services Covered by this Agreement, This agreement concerns the products listed in the table below. Note: List the products the supplier makes available to the customer. The list should be specific, but should not contain revision levels or other information at that specific level. For example, it would be better to say feed number: A1234. instead of the feed number: A1234 Revision C. You probably don`t want to re-approve the vendor contract for each product review change. Products covered by this agreement Product Name Supplier Part number Part number of the site (s) the supplier produces the product in one of the sites listed below. Karabin has teamed up with Jodi Scott, a lawyer at Hogan Lovells, to discuss how best to work with clients and suppliers, to ensure that these ambiguities are eliminated and that client agreements are clearer.