At medXteam, clinical data is our core focus. We collect this data through systematic literature searches or directly with the medical device during clinical trials. We already explained how literature searches serve as an interface and how data can be collected digitally in a post last year. We also act as quality management representatives for our clients, developing quality management systems in this context. These systems can also be digitized, which takes us another step further in terms of digitization and automation.

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

eCRF electronic case report form

EDC Electronic Data Capture

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Devices Implementation Act (MPDG)

1 Introduction

The medical technology industry has undergone a significant digital transformation in recent years. Technologies such as artificial intelligence and the Internet of Things have become driving forces revolutionizing how we develop and use medical devices. This digital shift also has implications for quality management, particularly in the context of medical devices.

Every manufacturer of medical devices is legally obligated to implement, maintain, and continuously improve a compliant quality management system (QMS) in accordance with the requirements of EU Regulation 2017/745 (Medical Device Regulation, MDR) and ISO 13485. This QMS forms a crucial pillar for ensuring both the safety and efficacy of the products and compliance with regulatory requirements and legal provisions.

In this digital era, designing a digital technology environment from our quality management system offers the opportunity to drive innovation, efficiency and sustainable improvements to workflows, providing numerous benefits including optimized efficiency, increased product quality and robust documentation and traceability capabilities.

2. Digitization of literature searches and clinical trials

We successfully implemented the integration of digital technologies over two years ago in the area of ​​literature searches for clinical evaluation as well as for clinical trials according to Articles 62, 74 or 82 of the MDR.

Digital literature searches enable a thorough and efficient collection of relevant clinical data necessary for assessing the safety and performance of a medical device.

Fig. 1 Literature search in the center

Literature searches can sometimes be very time-consuming and lengthy. Therefore, as part of the digitization of technical documentation, clinical evaluation, and in particular the literature search, was also digitized and the process automated.

Since medXteam focuses primarily on clinical data, literature searches are central. We implemented this process through our partner avasis , a certified Smart Expert Partner of Siemens Digital Industries Software in the areas of Teamcenter and Polarion.

Digitizing clinical trials improves data collection, analysis, and reporting, ultimately leading to more reliable results and more efficient processes. Our MaganaMed EDC system offers precisely this through the implementation of electronic clinical trial reports (eCRFs).

The close integration of clinical trials (whether for approval, within the framework of clinical evaluation, for the collection of product-specific data after market launch, or within the framework of a DiGA study) with the literature search process and thus with the clinical evaluation also necessitates the digitization of essential clinical trial documents such as...

• Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
• Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
• preclinical assessment

possible.

These digital approaches have proven extremely valuable and are setting new standards for transparency, efficiency, and accuracy. However, the impact of digitalization extends far beyond these areas. In a regulated environment such as medical technology, digitalization offers the opportunity to improve just as many aspects of quality management.

3. Digitalization in quality management

3.1 Advantages and necessity of digitizing quality management

Digital literature searches and clinical trials are essential components of today's research and development process in medical technology. They improve the efficiency and quality of data collection, analysis, and reporting. However, digitalization goes even further and significantly influences quality management.

It also offers numerous advantages: It improves process efficiency, thereby increasing the quality of medical devices and enabling better traceability and documentation. It also allows for more efficient QMS management. This is crucial for complying with the requirements of ISO 13485 and the MDR.

A digitized QMS enables seamless and centralized document management, more efficient and transparent auditing, and improved risk and process management. All these aspects are crucial for ensuring not only compliance with requirements but also the high quality of medical devices.

3.2 orgavision and the digitalization of quality management

In the rapidly changing world of medical technology, the digitalization of quality management is more than just an option – it's a necessity. With the right tools, medical device manufacturers can streamline their processes, improve their compliance, and ultimately deliver better products for patients.

One example of a tool for digitizing quality management is orgavision . This tool offers a wide range of functions that contribute to the digitization of quality management systems.

Orgavision enables companies to digitize and automate their quality management, leading to improved compliance and ultimately higher quality medical products.

Orgavision is a good example of a tool that supports the digitization of quality management systems. Orgavision's functions range from integrated digital document management to a comprehensive event management system (e.g., customer feedback, complaints, corrective and preventive actions).

Particularly noteworthy is orgavision's automation feature. One example is the automatic updating of process names. If a process name is changed in orgavision, this name is automatically updated in all documents where the process is explicitly linked. This avoids inconsistencies and misinformation, improving the accuracy and reliability of the documentation.

Orgavision also offers efficient audit management. Audits can be planned, conducted, and monitored, and the results can be easily integrated into the system and analyzed. This facilitates compliance with regulatory requirements and improves the efficiency of the auditing process.

orgavision is therefore a pioneering software solution specifically developed for the digitization and automation of quality management systems (QMS) in the medical field. It offers a wide range of functions that support the entire QMS process and contribute to increased efficiency. The following are further features of orgavision:

Change management: orgavision enables efficient change management by providing a structured process for handling change requests, approvals, and implementations. Digitizing this process allows changes to be quickly captured, tracked, and documented, improving control and efficiency.

Complaint Management: This tool offers features for effectively handling customer complaints. This includes recording, categorizing, and processing complaints, as well as tracking corrective actions. By digitizing complaint management, companies can respond more quickly to customer feedback, process complaints efficiently, and ensure continuous improvement in product quality.

Training: Orgavision enables the efficient digitization and optimization of training processes. The training matrix provides a comprehensive overview of the training requirements and current training status of all employees. You can define individual training elements, such as training events, courses, or webinars, for different employees or employee groups.

Let us now present this example in more detail:

Fig. 2 Training matrix orgavision

Each training course can be linked to relevant competencies, departments, or defined roles. This makes it possible to precisely identify which training courses are required for which employees and at what intervals. This systematic and structured approach ensures that no employee misses out on necessary training and that all employees always possess the required knowledge and skills.

Orgavision also offers the option of linking and managing training certificates directly within the system. Upon completion of a training course, relevant documents, such as certificates or confirmations, can be uploaded directly to the system and assigned to the appropriate employees.

These certificates are then accessible at any time and can be exported from the system if needed. Linking the training certificates not only simplifies the documentation and management of training courses, but also the verification of the training level of individual employees or entire teams.

4. Conclusion

The advantages of digitalization as a whole are obvious:

• more efficient work
• Target-oriented use of capacities
• Elimination of inefficiencies in the creation, maintenance and modification of content for technical documentation, clinical evaluation and literature searches, as well as in the area of ​​quality management
• Avoiding redundantly managed information/documents
• long-term reduction in care costs

By using digital tools like orgavision, companies can improve their quality management processes while ensuring their compliance.

The aforementioned functions of orgavision enable comprehensive digitization and automation of the QMS. This leads to improved efficiency, accuracy, and compliance. Centralized document management, workflow and process automation, and the digitization of change management, complaint management, and supplier management help optimize quality management processes and meet the requirements of ISO 13485 and the MDR.

In summary, digitalization in quality management absolutely simplifies processes, eliminates redundancies, and is therefore an absolute necessity in the long run. With the right tools and strategies, digitalization of quality management can lead to more efficient processes, improved compliance, and ultimately, higher-quality products.

5. What we can do for you

If a clinical trial is to be carried out, basic safety and performance requirements must first be met, and therefore essential technical documentation must be prepared.

Furthermore, all manufacturers of medical devices require a QMS, even when developing Class I products.

The clinical trial culminates in the clinical evaluation, which then in turn forms the basis for PMCF activities (including a PMCF study).

Therefore, we support you throughout your entire project with your medical device, always with primary reference to the clinical data on the product: from the beginning to the end.

6. How we can help you

At medXteam we clarify whether and if so which clinical trial needs to be carried out under what conditions and according to what requirements during the pre-study phase: In 3 steps we determine the correct and cost-effective strategy in relation to the clinical trial required in your case Data collection.

We also provide support in the areas of development strategy, technical documentation and quality management.

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation