Your product, manufactured under your brand
We are a contract manufacturer. You own or approve the design, the brand and the claims, and you place the product on the market. We manufacture it to the specification you approve and keep the records your quality system needs.
A clear split of responsibilities
For medical devices, the manufacturer under the EU Medical Device Regulation is the company that has the device designed and manufactured and markets it under its own name or trademark (Article 2(30) MDR). In an OEM project, that is you. You decide whether the article is a medical device and what it is intended for. We are your contract manufacturer: we make the article to the specification you approve and keep the records your quality system needs to show control over its supplier.
| Topic | You, the brand owner | Tysenco, the contract manufacturer |
|---|---|---|
| Design | Owns or approves the design and specification and is responsible for it, including designs we propose | Makes patterns and samples to it; may propose improvements for you to accept or decline |
| Intended purpose | Decides whether the article is a medical device, its intended purpose, class and claims | Makes no medical claims of its own; follows your labelling |
| Brand and labels | Provides label artwork, article codes and, for devices, the UDI data | Applies labels exactly to your approved artwork; label content stays yours |
| Regulatory file | Holds the technical documentation, CE marking and registrations | Supplies production records, material documents and change notices |
| Changes | Approves every change in writing | Makes no change to approved materials, critical suppliers, construction or production site without your written approval |
| Complaints and field actions | Handles complaints, vigilance reporting and any field action | Tells you promptly about any quality issue it finds and supports your investigation with production records |
| Production | Places the order, approves the sample and releases the product for the market | Produces, checks, packs and ships each order line under its own lot number |
Three starting points
You have drawings and a material specification. We quote, sample and produce exactly to them.
You have a product in service, made by another supplier or in your own production, and you hold the rights to its design. Send us one. We document it and propose a construction we can make consistently.
You have a need, not yet a drawing. We propose materials and constructions and make samples until the product does what you need. It becomes your article, on the terms we agree in writing. How development works
Documents with every project
We keep the documents your quality team will ask for, and we send them as agreed in your quality agreement.
- Approved sample record and the bill of materials for your article
- Supplier documents for fabrics and components as received for your article: technical data sheets, test reports, REACH SVHC declarations and OEKO-TEX certificates where the material holds one
- Production record per order line: lot number and quantities; material lots and inspection results as agreed per article
- Packing list and export documents, including the A.TR movement certificate
- Written notice before any proposed change, with nothing changed until you approve