MH
M. Hoek
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Development of a Regulatory Process Model for Non-Active Class III Cardiosurgical Medical Devices
Integrating EU MDR Requirements, Regulatory Documentation, and Institutional Stakeholders from Concept to Post-Market Activities
The development of high-risk medical devices under Regulation (EU) 2017/745 (MDR) requires developers to navigate an extensive regulatory landscape consisting of legislative requirements, standards, guidance documents, and interactions with multiple institutional stakeholders. Although these sources define individual requirements for regulatory compliance, they do not provide developers with an integrated overview of how regulatory activities, required documentation, and institutional involvement relate throughout the development process. This fragmentation can be particularly challenging for developers with limited Regulatory Affairs expertise and may result in regulatory requirements being considered only after development has already progressed. To address this problem, this thesis aimed to develop and validate a structured regulatory process model for non-active Class III cardiosurgical medical devices under the MDR. The model integrates development activities with the required documentation, applicable MDR provisions, and the institutional stakeholders involved from the initial concept through market entry and principal post market activities.
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool. ...
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool. ...
The development of high-risk medical devices under Regulation (EU) 2017/745 (MDR) requires developers to navigate an extensive regulatory landscape consisting of legislative requirements, standards, guidance documents, and interactions with multiple institutional stakeholders. Although these sources define individual requirements for regulatory compliance, they do not provide developers with an integrated overview of how regulatory activities, required documentation, and institutional involvement relate throughout the development process. This fragmentation can be particularly challenging for developers with limited Regulatory Affairs expertise and may result in regulatory requirements being considered only after development has already progressed. To address this problem, this thesis aimed to develop and validate a structured regulatory process model for non-active Class III cardiosurgical medical devices under the MDR. The model integrates development activities with the required documentation, applicable MDR provisions, and the institutional stakeholders involved from the initial concept through market entry and principal post market activities.
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool.
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool.