Dividing Lines between Design, Quality, and Regulatory Functions in MedTechDec 02, 2023
Written by Eric Sugalski
In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and regulatory functions. Questions arise about who leads the design control process, who participates in pre-submission (Q-Sub) meetings with the FDA, and who is responsible for verification and validation testing and reporting. While there isn't a one-size-fits-all approach, it's essential to establish clear boundaries between these critical functions to effectively develop a new medical device. In this article, we'll explore these divisions of responsibilities and provide insights to help navigate this intricate landscape.
To better understand the interplay between design, quality, and regulatory functions in medical device development, let's visualize their relationship in the Venn Diagram above. This diagram illustrates the overlapping areas where these functions intersect and the unique responsibilities each one holds. By examining this visual representation, we can gain a clearer understanding of how design, quality, and regulatory efforts converge to efficiently and effectively develop new medical devices.
Among the various functions involved in the medical device development process, the Design function takes the lead in the early stages. Design plays a pivotal role in converging on the right concept that meets technical, usability, and manufacturing requirements. Design engineers are responsible for generating detailed 2D drawings and specifications that serve as the blueprint for manufacturers to produce the final medical devices. They also conduct thorough failure analyses, such as Design Failure Modes & Effects Analyses (dFMEA), to identify and mitigate potential risks. Additionally, the design team is actively involved in testing to determine feasibility, characterize pre-production units, and carry out final verification and validation processes. In essence, the Design function acts as the driving force behind shaping the initial vision of a medical device and ensuring it meets the critical requirements.
The Quality function plays a crucial role in ensuring that all design activities and outputs align with company procedures and consensus standards, with the ultimate goal of mitigating risk and optimizing safety and reliability. The Quality team takes charge of managing a comprehensive Quality Management System (QMS), which often adheres to internationally recognized standards such as ISO 13485, as well as national regulations like the FDA's Quality System Regulation (QSR) and the EU's Medical Device Regulation (MDR). One of the key responsibilities of the Quality team is to lead the risk management process, encompassing activities such as risk management planning, risk analysis, implementation of risk controls, and reporting on identified risks. Additionally, the Quality function oversees the document change order (DCO) process, from initiation to change, release, and approval of documents. They also ensure proper documentation control and storage, whether in electronic or hard copy formats. By diligently managing these quality-related aspects, the Quality function contributes significantly to the overall success and compliance of the medical device development process.
The Regulatory function plays a vital role in ensuring that the necessary strategies are developed and implemented to support market clearance for medical devices. The Regulatory team is typically responsible for defining the device classification and determining the appropriate regulatory pathway to follow. They provide support in identifying predicate and reference devices for comparison in regulatory meetings and submissions. Additionally, the Regulatory function defines critical product labeling elements, such as Indications for Use and Intended Use, which are essential for conveying the device's intended purpose and ensuring compliance with regulatory requirements. The Regulatory team takes the lead in communicating with regulatory bodies, such as the FDA and other governmental agencies, and is responsible for completing the necessary filings to obtain approvals for clinical trials and market clearance. By effectively navigating the regulatory landscape, the Regulatory function plays a pivotal role in ensuring compliance and facilitating the successful commercialization of medical devices.
Where the lines blur..
While the design, quality, and regulatory functions have their defined roles and responsibilities, the development of a new medical device is inherently a collaborative process. For example, members from the Design and Quality teams work together in developing Design Inputs, conducting Risk Analyses, and preparing the Design & Development Plan (DDP). The Quality and Regulatory teams closely collaborate in determining the appropriate consensus standards to adhere to and prepare the necessary materials for regulatory submissions. Additionally, the Design and Regulatory teams collaborate closely in facilitating pre-submission (Q-Sub) meetings to address critical technical and regulatory inquiries. They also collaborate in developing comparative analyses between the new medical device and previously approved predicates or reference devices. Lastly, design, quality, and regulatory team members all play a role in the Design Review process, ensuring a cohesive approach and a fully aligned team that reviews and approves strategy and documentation throughout the development process.
While there are specific roles and titles that define team members fitting within these departments, it is common for individuals to wear multiple hats. This cross-pollination results in expanded understanding and appreciation of these various roles and functions. However, it is also important to understand that each of these domains requires a deep level of experience and skill in order to proficiently handle the activities required. So, while it can be enriching to delve into these areas, it can also be much more efficient and effective to leverage the expertise of subject matter experts. By allowing individuals to focus on their core competencies, teams can ensure that each aspect of the development process is handled with the highest level of proficiency. This collaboration between experts in design, quality, and regulatory functions ultimately leads to the successful development of medical devices.
If you're currently navigating the complexities of medical device development and find yourself in need of guidance or support, don't hesitate to reach out. Our team at Archimedic is here to help you with design, quality, and regulatory areas among others. Contact us today and let us help you accelerate and optimize your medical device development process. We're dedicated to your success and look forward to being a valuable partner in your journey. Reach out to us now and unlock the full potential of your medical device development with Archimedic.
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