Clinical Affairs
Competent support - the Clinical Packages from qtec
Placing a medical device on the market, thus establishing it there, and keeping it on the market stands and falls with the conformity of these products with all applicable legal specifications and requirements for the safety and performance of these products.
The requirements expected from a manufacturer to establish this conformity has risen because of the MDR. The focus of the new regulation is no longer on the reports, rather within the processes which are the basis for continuous successful compliance with the requirements.
On the 26th of May in 2017, the MDR was introduced and implemented, yet it has only been in effect since May of 2021. Because of this, the products that were placed on the market during this time, thus based on a valid MDD certificate are now understood as “legacy devices”.
- The best things come in small packages
- Editing processes and current documents
- Our PMS package - the best solution for a post-market surveillance system
- The next audit is coming!
- Literature Search Package
- Clinical Evaluation Package
- High Risk Package
- Post-Market Surveillance Package
- With our packages we give our best!
The best things come in small packages
Our team here at qtec is not only able to help with the fulfillment of requirements, but we are also eager to strategize how you might be able to optimize your process and how to implement these new possibilities.
Our clinical packages are there to help you achieve your goals. It does not matter if you are lacking resources or require factual support. Our team is well versed in areas like Medicine, Biology, Medical Technology, Chemistry, and Physics. We will use our regulatory knowledge and experiences within the work we have done with Notified Bodies or competent authorities to help analyze and find the best solutions to your questions, for you and your company.
Editing processes and current documents
We are eager to analyze and execute your most important processes and make sure that the relevant documents are up to date and valid. We will thereby also keep the interfaces in mind and provide your company with the gained information so that they can focus on new goals and prepare for the next audit.
We are happy to support you in the core process in the MDR: Clinical Evaluations and Post-market Surveillance. The Clinical Evaluation of your product is a continuous process. After the creation of a Clinical Evaluation Report, we will continue to regularly update based on the before-created Clinical Evaluation Plan. Of course, it is also possible that a situation may present itself that calls for an update of the before-mentioned Clinical Evaluation Report. If your Medical Device is risk-prone, we will also create a Summary of Safety and Clinical Performance (SSCP) that will entail results of the Risk Management and Clinical Evaluation.
The best solution for a post-market surveillance system is held within our PMS-Package
The Post-market Surveillance system is not a closed book - but it takes experience to establish appropriate methods in a company. The goal of a PMS system is the systematic and continuous recording of relevant and applicable data pertaining to the quality, performance, and security of a device. This data is then analyzed by our qtec experts. If anything is incorrect, the necessary steps must be taken.
We will apply our extensive experience and will lead the Post-market Surveillance process for your company. With this, we will show you that the hard work will not just equate to a simple document. Rather an aid to reveal future possible obstacles, which we can and will conquer together.
The next audit is on its way!
These are the types of packages we offer to best prepare you and your company for the next audit:
Literature Search Package
- Literature Search Protocol
Clinical Evaluation Package
- Literature Search Protocol
- Clinical Evaluation Plan
- Clinical Evaluation Report
High Risk Package
- Literature Search Protocol
- Clinical Evaluation Plan
- Clinical Evaluation Report
- Summary of Safety and Clinical Performance
Post Market Surveillance Package
- PMS-Plan
- PMCF-Plan
- Periodic Safety Update Report
- PMCF-Report
Literature Search Package
The Literature search package is our basic package. We will lay the foundation for your successful Clinical Evaluation; using the search terms we have assigned; you will start your literature research and the review of the publication. Through this process, you can be sure that the evaluation report is sufficient and can portray an accurate and current state of the art.
Clinical Evaluation Package
The clinical evaluation package contains all the services that are required for the Clinical Evaluation of your device. Together with you, we will create a clinical evaluation plan, as well as a literature search protocol, and will determine the evaluation report update periods that need to be upheld. We will create and refresh these according to the defined dates (regular updates) or as needed based on new insights that have been identified from your post-market surveillance process, for example (event-driven update).
High-risk Package
The high-risk package is based explicitly on manufactures of implantable medical devices and products that belong to the highest risk class III. The package further extends the content and requirements from the clinical evaluation package; for example, the preparation of the Summary of Safety and Clinical Performance (SSCP) report for devices. This report contains, among other things, the results of the clinical evaluation and is publicly available.
We recommend a combination of the high-risk package and the PMS package. With high-risk devices, the methods applied should work together seamlessly. Any mistakes can be noticed by your notified body; thus, leading to a fine.
Post-Market Surveillance Package
The Post-Market Surveillance Package was created with all classes of medical devices in mind. According to your PMS process, we will create a PMS-Plan, execute it carefully and record and document the outcome in a PMS-report or a Periodic Safety Update Report (PSUR). Additionally, this package withholds all the requirements that follow and result from a Post-market clinical follow-up process. Of course, these activities will be planned and documented by our team.
The post-market surveillance package is a great additional service to the clinical evaluation package and the high-risk package.
Our experts are more than happy to explain the benefits of our clinical packages in a one-on-one meeting. Please feel free to contact us!
With our packages, we will give our best!
You have created an innovative Medical Device and are ready to conquer the market? We are here to help you in your core processes!
We will take care to define and consider all interfaces. We will help you stay up to date!
News
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