Design Control Documentation That Brings Value to the Project and the Product

Our experienced team has assisted several MedTech companies in developing design control documentation that brings value to the project and product, and is consistent across all documentation, including labelling.

Design Control throughout a development project is about maintaining an overview, applying experience with product development, planning, and preparing documentation at a necessary and sufficient level. The formal requirement is that documentation for a medical device complies with ISO 13485:2016 and FDA requirements. In addition, documentation prepared at the right time provides valuable insights into the project and ensures consistency in traceability and across disciplines such as risk analysis, specifications, verification tests, validation and usability engineering. Project and design control experience are essential to minimize the risk of documentation-related delays — and instead contribute to project clarity and insight.

While focus during a development project is often on technical challenges, documentation challenges frequently arise as well. These occur when design control activities are initiated too late, documents are inconsistent, or labelling requirements are not incorporated into design control. Documentation may also become outdated or inconsistent with the product’s current state — for example, if the risk analysis and requirement specifications are misaligned. Such issues can result in missing inputs to the development process and late-stage changes. Addressing design control at the right time helps prevent these documentation-related problems.

Thanks to their experience, MGS Design & Development’s design control specialists can quickly gain an overview of both product and project, ensuring consistency throughout the documentation process. Labelling, as part of the product, must also be controlled in relation to both risk evaluation and verification activities.

For example, MGS Design & Development specialists assisted a leading MedTech company with its design control documentation and usability engineering file for a new medical device. The project’s main challenges were lack of resources and lack of documentation consistency at the time MGS Design & Development was brought in. The specialists supported development of design control documentation, planning of verification activities, and execution of the summative usability test. Specifically, they managed and conducted updates of requirement specifications, creation of a traceability matrix, and planning of verification and validation activities.

Design Control is not just about writing documents — it is about overview, experience, and collaboration across project functions (RA, QA, R&D, Marketing, Production). Design Control activities also help set the framework for both the project and the product.