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Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients

Rook Quality Systems offers comprehensive clinical evaluation services to medical device clients, assisting clients with navigating the development and regulatory approval process. Our strategy emphasizes the conduction of a Regulatory Evaluation and Assessment of the device to address FDA concerns regarding safety, effectiveness, and risk-benefit analysis, aiding in the device review process. In addition, it is crucial to assess the market value of the device and similar devices currently on the market. By assessing the device from both the business’ perspective and the user needs, we are able to properly advise the client on how to better design the device to fit the user needs better and how to deploy the product with the least burdensome regulatory approach, saving time and money.

Once a thorough evaluation of the medical device is conducted, the project lead will then draft a clinical validation protocol and plan based on their understanding of the device, FDA’s perspective and current business needs. This protocol and plan will include scientific-based justification of the methodologies used, comparative report analysis and establishment of relevant clinical endpoints. The Rook team’s focus is to identify gaps and determine best practices for mitigating future risks.

During the clinical evaluation process, the RookQS team serves as a liaison between medical device manufacturers and the Principle Investigator and IRB committee, assisting with the drafting of the Grant Proposal, shaping of the Clinical Study implementation plan, and through the generation of the Clinical Study Report.

RookQS Engagement

Thorough Understanding of the Device

Obtaining high-level technical knowledge of the device, its intentions for use, and target population, along with knowledge of similar devices currently on the market.

Determine the Client’s Current Stage of Development:

Early Stages of Development:

Our team will assist with designing the product to adequately serve the client’s business needs and ensure the least burdensome regulatory route. In addition, we will provide insight into available options such as the EUA program or a bundle submission, along with assisting with additional quality and regulatory assurance work. During this process, the client will be advised on the Clinical Validation Plan and Protocol.

Later Stages of Development:

If the client is at the point where they have an MVP in hand the only blocker is the lack of Clinical Study Report, then our team will focus on the conduction of the clinical study and developing the report. Depending on the case at hand, our team will determine what level of engagement is needed whether it be more thorough engagement or as simple as conducting a gap analysis and final review of the clinical study report or plan.

Determine Scope of Work:

Next, our team will work with the client to determine the SOW and their available resources. This will include an assessment of how the client’s team currently works together and interactions and then bring awareness of any areas of needs that the client may not initially be aware of. Once this assessment is conducted, our team will present the client with a concrete SOW, Gantt Chart, and a work plan. This will include the establishment of the communication channel, shared repositories, scheduling catch up calls, and sending frequent updates.

Rook Quality Systems stands as your trusted partner in the intricate journey of medical device development and regulatory approval. Our comprehensive clinical evaluation services, rooted in a deep understanding of device functionality and regulatory nuances, ensure not just compliance but also innovation and efficiency. By aligning with our expertise, you gain access to a tailored approach that minimizes risks and maximizes success, ultimately saving valuable time and resources. Let us guide you through every stage, from initial assessment to final deployment, as we work together towards achieving your goals in the dynamic landscape of healthcare technology.

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