Quotation for manufacturing checklist

20 January 2021 Resources

When you are ready to enlist a medical device manufacturer for your project, it’s vital that the documentation you provide is fully representative and comprehensive enough to enable an accurate quotation. Of course, if your device is designed in line with the Medical Device Regulation (2017/745 MDR), formerly the Medical Device Directive (MDD), you should expect the design package to be suitably equipped for any prospective manufacturer.

Your design package should include an accurate Bill of Materials (BoM) containing full component details and suppliers together with any information on parts that are either critical or technically challenging. It may be that your device relies on a particular supply chain or key vendors, and this needs to be understood at the earliest stage.

If you have already agreed on pricing for custom or key components with your elected supplier, ensure that you inform both your manufacturing partner and the supplier that the other exists. By doing so, you avoid confusion further down the line when your manufacturer’s price does not match your own because the supplier was not aware of any relationship.

We’ve created a checklist that provides a comprehensive overview of the project critical documentation and processes required to get your medical device into manufacturing.

Download our quotation for manufacturing checklist: