S5 E7: Academy Talks: Medical Device Documentation: Clinical Studies

As a startup company, post market surveillance can feel far away and not relevant, but key documents are of critical importance to develop during the device development process. The authorities expect companies to have a PMS procedure available and plans for surveillance of PMS and PMCF. We will walk through which active and passive collection methods are available for use to ensure the manufacturer has the data available to fulfil the requirements.

We discuss how to define the clinical study endpoints based on your defined safety and performance objectives and the clinical development plan during the clinical validation procedure. We walk through how to design different studies based on available standards and guidelines. Finally we will discuss the importance of the oversight of the clinical investigation and how to do that. We will also touch on the importance of selecting the correct participants and stakeholders to run an efficient and economical clinical investigation.

During this session, we will walk through how to translate the requirement specifications into a verification and validation plan, including setting up bio compatibility studies, animal studies and bench test and usability tests, etc. We will discuss how to maintain the traceability from the requirements to verification and validation methods. The importance of design freeze during this process is discussed further.

We will walk through the clinical evaluation process starting with the clinical evaluation plan and the literature search as the initial steps to identifying the clinical safety and performance objectives. These two procedures are built on a vigilant search of publicly available databases and establishing a state of the art description of similar and equivalent clinical procedures and devices. The output is the clinical evaluation report. We will additionally walk through who can and when to establish the process of clinical evaluation and how to continuously update the documentation.

This session will walk you through the overall risk management process. Starting with the description on the risk management plan and how to work with the risk management analysis/HTM matrix. This process is built on several input sources that we will highlight during our discussion and finalise in our risk management report, identifying the final residual risks.  The risk management documentation is evaluated during the risk management review process as established in the companies. We will finally highlight how to update the ongoing risk management documentation.

Now that you have your user needs description,  we will walk you through how to set the user and device related requirements supported by the list of applicable standards and the device description. Once we have this in place, we will be able to define our clinical claims and clinical and non clinical objectives, Again, we highlight the importance of updating the ongoing documentation throughout the development process.

We will continue the development of the device description and based on that define our intended user and patient population. We will also discuss what input sources to use and how to create the specific documentation. We will also touch on concept testing that can be used to develop the early stage documents. We will walk you through how to update your user input documents.

In our first episode, we will discuss the importance of the device description and the link to the other standalone documents, such as classification, GSPRs, regulatory compliance plan, instructions for use and the list of applicable standards. This will enable you to start out on the right foot with your medical device development project. We hope you find this series helpful! You are so welcome to let us know your thoughts and if you have any questions by commenting below or emailing us at [email protected].

During this episode we will have CETAS Healthcare share their extensive knowhow and perspective on how to set up PMCF surveys and gather important data fulfilling the MDR requirement.