Hello, my Name is Dr. Sebastian Grömminger. I hold a PhD in molecular biology, worked as paramedic and screen designer. Equipped with that scientific, medical and technological knowledge and experience I entered the MedTech industry in 2012.
The Start-Up Chapter
At a start-up in Constance, Germany We developed a successful IVD Medical Device Software (MDSW) for Non-Invasive Prenatal Testing (NIPT) based on Next Generation Sequencing and quantitative PCR. Over five years I was responsible for building and growing the laboratory, automation of processes, PCR Assay development, validation of processes and computer software that we developed in house. I took over the responsibility for Quality Management and Regulatory Affairs including design and change control of the IVD MDSW and with that I significantly contributed to the company growth, profitability, continuous compliance and successful launches of product features under notified body surveillance. I left the company shortly before the acquisition by a global laboratory analytics enterprise in 2017. At the same time the EU as put the new medical device regulations (MDR and IVDR) in force and the tiny word “Software” was added to the definition of an In vitro diagnostic medical device (IVD) and that completely changed my life.
The Consulting Chapter
With MDR and IVDR in force I knew that I do not have to worry about my job over the next ten years to come, so I joined a small Consulting Company nearby that was quite present in the web but obviously lacking deeper knowledge about IVD. So I was keen to fill out that gap. During the time the new regulations were implemented in the MedTech Companies, I designed my own IVDR Seminar, consulted on Qualification and Classification of medical device Software and IVDs, built templates for technical documentation and Quality Management Systems, trained various stakeholders, students and authorities on how to interpret and implement MDR and IVDR requirements. In 2023 I moved to another consulting company where I consulted on a strategic basis on director and management level in various mid size and global enterprises. My work focussed on portfolio IVDR transition strategies, Clinical Evidence strategies, AI-based Post-Market Surveillance methods, Return on Investment calculations, Digital Maturity Assessments, Post Merger Integration strategies and Project Management involving several consultant and client roles. During that time the development of AI-based applications utilizing Large language Models to perform time consuming tasks, collecting, sorting and extracting information as well as generating regulatory reports excited me. A first successful project encouraged me to redefine my profession.
The AI-Regulatory Advisor Chapter
In April 2025 I decided to join a start-up providing a digital solution for Technical Documentation and a fully digital Quality Management System. But not just a digital platform, it is equipped with AI-functions to alleviate the pain of data migration and awful manual document transfer. It is a fully data driven platform with single source of truth items connected to devices, device families, templates, forms processes and submission dossiers. On top of the validated cube, AI-Agents are acting on the data to perform regulatory and quality management tasks with the expert user in the loop. My role here is to ensure that the users can achieve their objectives with the tools, functions and agents provided while being compliant to standards, regulations based on acknowledged best practices that I developed and applied in consulting.
Besides that I am still providing strategic consulting but now on a freelance basis and just one day per week. So if you wish to benefit from my experience knowledge and competences, reach out.
Groerilla Silverback Consulting
Expertise in MedTech – Unlock Innovation Today