The latest writings from our team

A Successful November at MEDICA & Infomarkt der Möglichkeiten From Düsseldorf to Mannheim: November 2025 was a milestone month for meddevo. Discover how we strengthened regional ties with Medical Mountains, welcomed our new client psilkon, and shared expert insights on digital conformity assessment. Read more about our latest networking achievements, CEO Michael Kania’s thought leadership, and the team spirit that drives our innovation.

Using AI for technical documentation? Think again. Discover why unstructured formats like PDFs and Word files lead to critical errors - and how structured, content-based data models unlock the true potential of AI in regulated environments like MedTech.

Our 5-day offsite in Görlitz/Zgorzelec brought the meddevo team together across departments to collaborate in new ways - without silos or hierarchies. From workshops on AI and diversity to immersive theater, lake swims, and local cuisine, the week was all about connection, creativity, and team spirit.

Team-NB’s new MDR guidance highlights inconsistency in documentation as a key cause of delays and rejections. meddevo addresses this with a Single Source of Truth that keeps all files aligned automatically—ensuring real, practical consistency across your technical documentation, not just in theory.

The co-CEO model offers significant benefits for companies navigating complex challenges, such as digital transformation and agile management. By splitting responsibilities, one CEO focuses on strategy while the other manages operations, enhancing decision-making and fostering innovation. Key success factors for a co-CEO structure include clear role delineation, shared values, and effective conflict resolution. At meddevo - dytab GmbH, the dual leadership model drives collaboration, strengthens succession planning, and ensures a more stable, diverse, and agile organization. Embracing these principles supports long-term growth and innovation.

Updating standards in medical technology is crucial for product safety and regulatory compliance, yet the process is often inefficient and reactive. Relying on outdated tools like Excel can lead to missed updates and nonconformities in audits and TD reviews. To optimise this, follow five steps: (1) Centralise and document all relevant standards, (2) Train teams for correct application, (3) Monitor updates regularly, (4) Maintain detailed implementation records, and (5) Implement changes efficiently, preferably using digital management tools. A proactive standards process enhances safety, compliance, and operational efficiency.

In our regulatory affairs world, precision isn’t just important - it’s kind of everything. A misplaced word, a wrong issue date in a standard reference, or an outdated document reference in the GSPR document (ANNEX I) can mean the difference between compliance and costly delays in reviews or registration projects.

In today’s digital landscape, the role of Junior Regulatory Affairs (RA) professionals is evolving rapidly. As companies digitalize their Regulatory Affairs Departments, they unlock significant advantages by including Junior RA roles. These roles benefit both the professionals and the companies they work for. Let’s explore how digitalization is transforming the learning journey of junior RA professionals and why this is advantageous for businesses.

Are you ready for a digital Regulatory Affairs department? Join our live webinar on the latest advances in digital documentation, automated approval processes and general process digitization.

A common misconception among manufacturers is to understand biocompatibility compliance as the need for extensive laboratory testing. However, under the MDR and according to ISO 10993-series, the focus is on evaluation — a concept that encompasses much more than just testing.

The future of regulatory consultancy is bright and unmistakably digital. As we embrace these changes, both consultants and manufacturers stand to gain from more effective, outcome-focused services. The shift towards digital platforms and productized knowledge is not just a trend; it's the new reality of our industry.

This post explores the challenges of managing redundant information in technical documentation for the In Vitro Diagnostic Regulation (IVDR) It highlights the potential pitfalls, document management issues, and the need for a more efficient approach. The post introduces meddevo as a solution to revolutionize and streamline product information management, ultimately enhancing regulatory compliance.

In the medical device and IVD industries, technical documentation isn't just paperwork-it's a regulatory requirement. The method you choose to create and manage this documentation can have a significant impact on your workflow, compliance, overall efficiency, and costs. In this article, we'll look at five common methods. A comparison of apples and oranges, but one that must be made. Clouded by 12 years of Regulatory Affairs pain, I dare to make the comparison. What would a comparison be without a rating or a comparison chart? However, since it is extremely difficult in this case, and there is subjectivity involved, we will only do a subjective rating. Remember, we are looking at this through the regulatory lens.

The recently published white paper by BVMed and VDGH has caused a lot of discussion in the medtech industry. Among other things, it calls for the abolition of recertification and a fast-track procedure for innovations. We at meddevo.com think this is an important step in the right direction and would like to share our view on the role of digitization in this context.

In the medical device industry, technical documentation is paramount. A recent survey, however, uncovers a concerning fact: 80% of notified bodies report that half (50%!!!)of the required information is missing in the submitted documents.

Do these products belong together?! Issues with Product Groups and Scope of Technical Documentation

When dealing with powerful tools, whether a medical device or a sophisticated artificial intelligence software, a clear understanding of their intended purpose is critical. In the field of AI, one of the most common misunderstandings arises from the use of tools such as ChatGPT, an advanced language generation program from OpenAI.

In the ever-changing landscape of regulatory affairs, companies are constantly looking for efficient solutions to automate their Medical Device Regulation (MDR) and In-Vitro Diagnostica (IVDR) reporting. This is where Electronic Technical Documentation (eTD) comes into play. The benefits of implementing an eTD system are numerous, and even greater for companies that maintain multiple technical documentations and have products registered in multiple countries.

The General Safety and Performance Requirements (GSPR) outlined in Annex I of both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial elements that every manufacturer should pay close attention to. They provide specific guidelines and expectations for ensuring the safety and performance of in vitro diagnostic devices. In this blog post, we will explore the importance of GSPR and why they should be a focal point for manufacturers.

The In Vitro Diagnostic Regulation (IVDR) has introduced a new era for IVD manufacturers, introducing a risk-based classification system that is fundamentally different from its predecessor, the IVDD. This shift from list-based categorization to risk classes is a significant change, and understanding these classes is critical for compliance.