Ensuring traceability in the contract manufacture of medical devices

Traceability is a crucial part of the medical device manufacturing process and plays a critical role in ensuring product quality and safety. The contract medical device manufacturer that you use should operate a comprehensive traceability framework.

The function of a traceability framework is to provide a clear roadmap of the medical device manufacturing process, encompassing supply and distribution. It details why, how, where and when a product has been manufactured.

Why traceability in medical device manufacture is important

There are three main reasons why traceability is important in the contract manufacture of medical devices.

    1. Better supply chain visibility. When traceability is applied throughout the manufacturing process (design, production and sale), a manufacturer can quickly and easily trace from across the supply chain the origin of the materials and components used in the manufacture of a medical device.
    2. Improved quality control. Traceability is a key part of ISO 13485 and ISO 9001 international manufacturing quality standards, and a comprehensive traceability framework helps to prove compliance with these standards. This traceability and the various formats that it takes, including through the use of labels, laser etching, barcodes and moulded stamps on medical devices, also helps fight against counterfeiting. It guarantees product authenticity and protects brand reputation.
    3. Reduction of risk. A comprehensive traceability system ensures better recall management. In the case of any issues, such as a defect (which doesn’t necessarily have to come from the manufacturing process), a manufacturer can react quickly if it has a detailed supply, production and distribution history on record. Materials and components can be easily tracked and replacements quickly matched.

What traceability you should expect from your contract manufacturer

When you choose a contract medical device manufacturer, you should ensure that they operate a comprehensive traceability framework. There are many benefits to working with a contract manufacturer of medical devices and such a framework should be one.

The traceability framework should comprise a range of processes and features that help ensure product quality and safety. These include:

  • The checking and inspection of all components when they arrive at the contract manufacturing base. After the components have passed inspection, they should be assigned a receipt ID. The component number, quantity and lot number should be recorded on a materials requirement planning (MRP) system.
  • When a production batch is raised, the MRP system should generate a component picking list in relation to the batch number level. The components selected are then issued to the manufacturing job.
  • Each medical device production job should be allocated a production batch number, which can be clearly linked to individual component data.
  • Any components that remain following the completion of the medical device manufacturing job should be logged on the MRP system and returned to the relevant stock batch.
  • Finished medical device products should be dispatched with a certificate of conformity that shows the lot number, production date, sterilisation date and certificate number, if applicable.
  • All Meridian Medical device product records are held as standard for 10 years from the date of last component production. Storage capacity is available if a longer period of document retention is required, for example, with implants.

Meridian Medical operates a comprehensive traceability framework that includes all the processes and features listed above. This focus on traceability is part of our commitment to the highest quality standards in everything we do as part of our end-to-end service.

Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.

To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.

Ensuring traceability in the contract manufacture of medical devices