qtec Spotlight - Focus on one subject area
In our daily work, we focus on the typical life cycle of Medical Devices. Our experts support companies throughout the entire Medical Device approval process and are active in a wide range of areas. With our new Spotlight series, we will spend a quarter year taking a closer look at one of these areas and publishing the expertise of our experts in bundled form on various channels.
Quarterly themed specials
We take pride in the expertise of our employees. That's why they are encouraged to share their knowledge of Spotlight topics. Each quarter focuses on a different topic. To this end, expert articles are published in our news section on our website and expert videos are created and posted on our YouTube channel. As a rule, we hold an info lunch toward the end of each quarter. At these events, which are currently held digitally, we inform a selected small group of participants about the main topic.
Spotlight 2/2023 “Post-Market Surveillance”
Post-market surveillance remains one of the most controversial topics surrounding the introduction of the MDR. Undoubtedly one of the most extensive processes undertaken by any company, post-market surveillance requires perfect collaboration between risk management, clinical affairs and labelling.
Safety of medical devices
Post-market surveillance is used to ensure the safety of the products. In an ideal scenario, after development is complete, a product that meets the specifications is placed on the market. But even then, some faults might only become noticeable during application. PMS ensures that non-conformities can be detected as early as possible and rectified quicky.
Every day, we observe that our customers are unsure which activities are considered appropriate in the context of PMS and how the collected data should be evaluated. This applies to the European market, but also to the USA or China, where similar market surveillance requirements are in place. With our spotlight, we want to shed some light on this issue.
Our technical articles provide answers to urgent questions, for example relating to market research of publicly available databases or PMS regulations and guidelines in China. Make sure to keep any eye out for more information, so you do not miss our info lunch. The best way to do this is to follow us on LinkedIn! If you have any questions, you can contact our IVD experts at any time.
Content provided by our experts
Our experts have created some additional exclusive content. You can access their contributions here:
Spotlight 4/2022 „IVDR“
The In Vitro Diagnostics Regulation (IVDR) replaced the IVDD on May 26, 2022. However, many manufacturers are not yet aware of the requirements already in place. Currently, the requirements only have to be implemented by non-sterile IVDs of risk class A and products that previously did not have a certificate under the IVDD. So-called legacy devices of higher risk classes can still be made available on the market by taking advantage of the transition periods.
The IVDR and the MDR
In may of 2022 the In Vitro Diagnostics Regulation (IVDR) replaced the IVDD. However, many manufacturers are not yet aware of the requirements already in place. Currently the requirements must only be implemented by non-steril IVDs of risk class A and products that previously did not have a certificate under the IVDD. So-called legacy devices of higher risk classes can still be made available on the market by taking advantage of the transition periods.
There is much to learn from the introduction of the MDR, as there are many parallels: IVDs will soon need a unique device identification sytem (UDI system), risk management and post-market surveillance are gaining in importance, and above all, the performance evaluation of individual products will now play a major role and consolidate many processes. Also, there are currently only seven Notified Bodies accredited to handle the flood of certification requests.
Even in house IVDs, which were not regulated at all before, now fall within the scope of the IVDR. Our first blog post pertaining to this topic, covers this subject, and contains everything you need to know.
In our third Spotlight Q4/2022, we will take a closer look at the IVDR. We will try to clarify the most pressing issues, such as how to properly classify an IVD, and provide tips on how to create a compliant performance evaluation. Be sure to keep your eyes peeled so you don't miss the info lunch. The best way to do this is to follow us on LinkedIn! If you still have questions, you can reach our IVD experts at any time.
The contents of our experts
Our experts have once again created exclusive content. We start our Spotlight 4/2022 with the following article:
Spotlight 3/2022 „Software & medical technology“
The topic of "software" is currently very popular in medical technology. However, this term is far too general. What is explicitly meant by "software" when it comes to the development of Medical Devices, regulatory affairs or quality management? The areas and uses are diverse and even the addition of "medical technology" does not clarify much - the topic remains vague and imprecise. Similarly problematic is the understanding of manufacturers of Medical Devices for the diverse challenges that this extensive subject area entails.
Software and Safety - FDA Guidance for Cybersecurity
Only in April this year did the FDA release the final guidance for cybersecurity. The long awaited document handles important components of software safety for Medical Devices in the US market. In general, the topics software and cybersecurity are only to be assessed as a whole.
Software in Medical Devices or software as a Medical Device?
Software is everywhere and ubiquitous. Companies that manufacture Medical Devices and bring them into the market, are often faced with the same questions:
- When is a software a Medical Device?
- What happens to a software that is integrated in a Medical Device when the software is updated or changed?
- What tools are available to support the lifecycle management of medical technology?
- How can tests necessary for approval be carried out?
- How can a so-called “Digital health application” be brought to the market?
- How do you document the development of software in a comprehensible way?
- How can a KI-application be successfully verified?
- What potential hazards should you expect as a manufacturer and what is the best way to arm yourself against them?
There is no trivial answer to any of these questions and there are even fewer established standards. In order to clarify at least a few of the unanswered questions, our experts have taken up the topic of software - as large and imprecise as this term may be - and made it the spotlight topic of the third quarter of 2022.
The contents of our experts
Our experts have once again created exclusive content. We started our Spotlight 3/2022 with the following article:
Launch of our Spotlight 2/2022 "Biocompatibility
The overarching theme of our current Spotlight is "Biocompatibility" as material characterization and chemical analysis for medical devices becomes more extensive.
With the publication of the updated ISO 10993-18 standard in 2020 and its associated requirements, the upswing in:
- Introduction of analytical identification threshold (AET) followed by increased sensitivity of test methods.
- Identification of hazardous ingredients, decomposition products, and impurities in medical devices and determination of potential content in the medical device itself.
- Additional test methods for the analysis of non-volatile substances leading to the detection of unknown substances.
- New extraction conditions are in the foreground (exhaustive extraction versus enhanced extraction)
Chemical analysis in the context of biological evaluation
The purpose of chemical analysis is to identify biological hazards and use exposure assessment to evaluate risks and avoid animal testing. Therefore, the identification of unknown substances and their toxicological characterization is crucial.
Discover content from our experts
Our experts have created exclusive content on the topic of biocompatibility. Find the right post now.
Our videos explain facts in an understandable way and provide additional background information. Here you can find our Expert:in videos.
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