The latest writings from our team

A new Horizon Europe project wants to replace PDFs and spreadsheets in MDR and IVDR conformity assessment with structured, machine-readable data. Here is what DIGICAP is, what it is not, and what you can sensibly do before 2029.

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.

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.

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 Relying on outdated tools like Excel can lead to missed updates and nonconformities in audits and TD reviews.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 A misplaced word, a wrong issue date in a standard reference, or an outdated document reference in the GSPR document (ANNEX I) can mean the difference between compliance and costly delays in reviews or registration projects.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.

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.

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.