Medical device design and development is a structured process that ensures devices brought to market are safe, effective, and compliant with applicable regulatory requirements, including the EU MDR and ISO 13485. The process provides a systematic framework covering all phases from concept development through design verification and validation to market launch and post-market activities, ensuring both regulatory compliance and product performance throughout the device lifecycle.
House of MDR can provide
The readability user testing and labeling is evident in their shared goal of promoting safe and effective medical device usage. Usability testing helps inform the development of clear and user-friendly instructions, while labeling ensures that users understand how to use the medical device safely and avoid potential risks.
House of MDR can provide through its cooperation network wide range of clinical evaluation services such as
Clinical evaluation is a mandatory, systematic and scientifically justified process aimed at demonstrating that a medical device meets the safety, performance, and intended use requirements under Regulation MDR 2017/745.
House of MDR can provide through its cooperation network wide range of biological evaluation services like
The biological evaluation report is needed as a part of the regulatory approval and requires top expertise in the biological risk evaluation of medical devices, taking into account the requirements of ISO 10993- standard family. It is a comprehensive analysis considering toxicological evaluation as well as appropriate chemical and biological tests of the extractables that could be released from the device during its usage.
We provide the expertise and capability to help you identify the optimal formulation and manufacturing process for your product, ensuring full compliance with regulatory requirements and associated documentation, while maintaining cost-efficient production. In addition, we support projects related to technology and production transfer. Leveraging our extensive network of trusted partners, we can also assist in identifying a suitable contract manufacturer for your product.
