Our experienced team has assisted several MedTech companies in developing design control documentation that brings value to the project and the product and is consistent across the entire documentation, including labelling.
Design Control through a development project is about overview, experience with product development, planning and of course preparation of documentation at a necessary and sufficient level. The formal requirement is that the documentation for a medical device shall comply with ISO 13485:2016 and the FDA’s requirements. In addition, it creates great value for a development project when the documentation is prepared at an appropriate time so that it provides insights into the project, and is consistent both in terms of traceability and between the individual disciplines such as risk analysis, specifications, verification test, validation and usability engineering. Project experience and design control experience are essential to navigate appropriately so that risk of project delays caused by documentation is minimized – and instead contribute to overview and insight.
Focus during a development project is naturally on the challenges related to development of the product, but challenges are often related to documentation as well. These challenges arise when the design control activities are initiated at a late stage, when the design control documents are not consistent or when labelling requirements are not included in design control. Due to focus on the technical challenges of a project, the documentation is perhaps also not kept updated and is inconsistent with the current state of the product or the design control documents themselves are inconsistent – e.g. the risk analysis and the requirement specification is inconsistent. This leads to risk of lack of input to the development process and hence late stage changes. Taking design control into account at an appropriate time, will help prevent these challenges related to documentation from happening.
Due to the high level of experience, Technolution’s design control specialists can quickly gain an overview of the product and the project to ensure a red thread during the design control documentation process. The labelling is part of the product and shall also be in control, both in terms of the relation to the risk evaluation and in terms of the relation to verification activities.
As an example, Technolution’s specialists were hired to assist with the design control documentation and usability engineering file of a leading medtech company’s new medical device. The two main challenges for the project related to documentation and usability engineering were lack of resources and lack of consistency at the time when Technolution was introduced to the project. Technolution’s specialists assisted in developing the design control documentation and planning of verification activities and the summative usability test. In detail, Technolution’s specialists managed and conducted hands-on development and update of requirement specifications, creation of traceability matrix and planning of verification and validation activities.
Design Control is thus not just about writing documents, but about overview, experience and collaboration across the functions of a project: RA – QA – R&D – MKT – PRO. The Design Control activities often also help set the framework for a project and product.
Ole JakobsenOwner / Axlab
Development of medical devices is a long and complicated process that Technolution has carried out with great expertise.
Lars HansenGeneral Manager / PowerSense
Technolution is a competent development partner who takes on the task and delivers results beyond our expectations regarding both quality and speed.
- Risk Management (ISO 14971:2012)
- Usability Engineering (IEC 62366-1:2015 and FDA guidance on Human Factors)
- Design Control, e.g.:
- Requirements Specification
- Traceability Matrix
- Verification and Validation Plan
- Test Protocols
- Labelling including Instructions for Use (IFU)
- Assessment of patents
- Assessment of product specific standards