When you’re ready to enlist a contract manufacturer, it’s vital that the documentation you provide is fully representative and comprehensive enough to enable an accurate quotation. Of course, if a device has been developed following the Medical Device Directive (MDD), you would expect the design package to be suitable equipped for any prospective manufacturer.

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

If you’ve already agreed pricing for custom or key components with your elected supplier, make sure that you inform both the manufacturer and the supplier that the other exists. This avoids confusion later on when the manufacturer’s price does not match your own because the supplier was not aware of any relationship.

Click below to download our handy infographic that provides an overview of the project critical documentation and processes required to get your device into production.

How can we help support production of your medical device or IVD? Complete our enquiry form here or email us at ask@itl.co.uk.

Read our latest resource ‘Thinking Medical Device Contract Manufacturing? Think ITL Group

Read a medical device manufacturing case study, click here.

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