Design Control

Design Control
Every medical device starts with an idea. Then this idea has to be transformed into a product that is safe and efficient. Easier said than done. To keep the overview, Design Control provides some useful tools. Requirements will be defined and foreseeable risks identified. Subsequently, it is verified whether the product meets the defined requirements and whether the benefits expected by the user and patient are achieved (validation). The process is concluded with the design transfer, i.e. the transfer of the development results to production, and manufacturing can begin.
Each step of the development process must be documented. Whether a manufacturer chooses one of the common models for this (waterfall model or V-model) or not - it is important that the basic sequence of the individual steps in the development process is adhered to. To successfully complete a development process, you need both experience and an understanding of the dependencies and sequences in such a controlled process.
Currently, many companies are facing challenges in the development of software and AI applications. Especially when the verification of such products is still little practiced. Our experts can also support you in these projects and accompany you all the way to the finished product.
Design Control
Performance portfolio
News
Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs
The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).
Opportunity and challenge: Regulatory requirements for AI-based medical devices
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.