A fully developed device and a device ready for production are two different things. At the end of the development process, you have a product that works. But what’s still missing is a detailed set of instructions that will allow others to manufacture this product in series.
To achieve this, drawings, prototypes, and test reports must be transformed into manufacturing documentation, test procedures, and supplier approvals. In addition, a production line capable of manufacturing the product is required. ISO 13485, in Section 7.3.8, specifically requires this evidence. The development results must be verified for manufacturability before they become final production specifications.
The same change, but at a fraction of the cost
How much feedback from production costs depends on when it arrives. If production reports during the concept phase that a tolerance cannot be met economically, this amounts to a few hours of design work. If the same feedback comes after verification has been completed, the change necessitates a reassessment of testing requirements, an update to the risk analysis in accordance with ISO 14971, and an update to the technical documentation. Hours turn into weeks, and the planned market launch is delayed.
Is it even possible to build and assemble this?
Design for Manufacturability means that a design can be manufactured in a practical manner. Key questions here include, for example:
- Can the mass-production supplier meet the selected tolerance cost-effectively?
- Is the material available in production quantities and in medical-grade quality?
- Can the assembly still be inspected after it has been put together?
Design for Assembly means that the product can be assembled easily. Questions that arise in this context include, for example:
- Can a component be inserted only the right way around, or can it also be inserted the wrong way?
- Is the screw hole accessible with the tool?
- Does the assembly require twenty parts, or would eight suffice?
Decisions of this nature are made early in the development process and have an impact throughout the entire product lifecycle. An assembly step that takes twenty seconds too long costs money year after year when producing five thousand units annually.
Design, certify, manufacture: all under one roof
We handle development, certification, and manufacturing all under one roof. This is crucial for the design transfer process, as it takes place precisely at the intersection of these three areas. We design the manufacturing process, create work instructions and test reports, qualify suppliers, and build the necessary fixtures and test systems.
Our production lines in Darmstadt and Höhn have been approved through installation, functional, and performance qualification, and our processes and test methods have been validated. The end result is not a presentation, but a pilot production run from our own manufacturing facilities. It’s up to you to decide whether you’d like to have your device manufactured by us afterward or transfer production to your own facilities.
Frequently Asked Questions About Design Transfer in Medical Technology
Design transfer refers to the documented process of converting development results into approved production specifications. It ensures that a medical device can be manufactured in series in a reproducible, safe, and standards-compliant manner. This includes manufacturing documentation, qualified equipment, validated processes, and evidence that production actually meets the product requirements.
Design transfer begins at the start of the project, not only after verification and validation. Experts in manufacturing, quality management, and regulatory affairs should be part of the team from the very beginning so that production requirements are incorporated into the design early on. This helps you avoid late-stage design iterations, schedule delays, and high additional costs shortly before your product’s planned market launch.
ISO 13485:2016 addresses the design transfer in Section 7.3.8. It requires documented procedures, verification of the development results for manufacturability prior to the release of the final production specifications, and evidence that production can meet the product requirements. The results and conclusions of the transfer must be recorded and verifiable during an audit.
The EU MDR does not explicitly mention the design transfer, but it is implied by the quality management system in accordance with ISO 13485. In the U.S., the QMSR has been in effect since February 2, 2026; it references ISO 13485:2016 and replaces the former 21 CFR 820.30(h). The requirements are thus largely harmonized.
The development file, known as the Design History File in the FDA context, documents how the product was developed and validated. The Device Master Record provides a binding description of how it is manufactured, tested, packaged, and released. The Device History Record verifies for each individual batch that production was carried out exactly as specified. Auditors track this chain seamlessly.
Design for Manufacturability assesses whether a design can be manufactured economically using stable processes, available tolerances, and qualified suppliers. Design for Assembly determines whether the product can be assembled and inspected safely, quickly, and with minimal errors. Both approaches are implemented early in the project and significantly reduce scrap, lead times, and unit costs later on.
Process validation provides documented evidence that a manufacturing process consistently produces compliant products. Installation qualification verifies that the equipment has been installed correctly; functional qualification verifies performance within process limits; and performance qualification verifies production readiness under real-world conditions. In addition, test equipment and test methods are validated to ensure that measurement results remain reliable and reproducible.
Yes. Even after verification is complete, a design transfer can still be carried out. We begin with a gap analysis of development files, manufacturing documentation, and supplier status; we prioritize the critical gaps and implement necessary design changes in a controlled manner through change management. We then qualify the production line and manufacture a pilot batch as solid proof of production readiness.
Design transfer involves transitioning a newly developed product into mass production for the first time and is part of design controls. Production transfer involves moving an already ongoing production run to another location or manufacturing partner. Both require qualified equipment, validated processes, and up-to-date manufacturing documentation, but differ in terms of their regulatory starting point and the level of effort involved.
Tell us what stage your project is at
Give us a brief overview of where your project currently stands. We’ll let you know which steps are still needed to ensure a robust design transfer and which of those are time-sensitive.
Or we can work with you to plan a new product from the ground up. We look forward to hearing from you.