Ensure your medical device software meets the full scope of EU MDR 2017/745 regulation requirements. QMLogic provides expert EU MDR consulting services, guiding you from gap analysis and documentation to CE certification and post-market activities.
We evaluate your product's current regulatory position and develop a clear path to EU MDR compliance:
Our team combines deep expertise in MDR Regulatory Affairs with hands-on experience guiding software and digital health products through EU MDR compliance, CE certification, and long-term audit readiness.
We specialize in EU MDR consulting for software and connected devices, including:
We have successfully guided multiple companies through:
We design medical device compliance strategies aligned with the requirements on a QMS System:
EU MDR 2017/745 is a set of regulatory requirements spanning quality management, technical documentation, clinical evidence, and post-market activities. Effective EU MDR compliance therefore requires:
EU MDR compliance demonstrates that your medical device is safe, effective, and developed under a robust and controlled regulatory framework.
Beyond legal access to the EU market, it reflects organizational maturity and long-term commitment to quality, patient safety, and regulatory excellence.
We guide you through EU MDR with practical insight tailored to your organization's goals, internal capacity, and current product development stage, ensuring an efficient and realistic compliance strategy.
We go beyond advice by actively closing compliance gaps, preparing required documentation and processes, supporting audits, and communicating directly with auditors to ensure execution, not just recommendations.
We take full ownership of your MDR certification by defining scope, timelines, and budget, then leading and reporting on the project until successful certification is achieved.
We deliver integrated MDR compliance by aligning quality management systems and technical documentation into one consistent, efficient regulatory framework.
Our MDR consulting team includes medical doctors and PhD experts in molecular biology, genetics, and oncology, ensuring all clinical aspects of your product are addressed with scientific and regulatory rigor.
We design MDR compliance, QMS, and post-market activities to be efficient, lean, and sustainable, supporting long-term feasibility without unnecessary bureaucracy.
We support you beyond certification by providing ongoing MDR expertise for new products, QMS improvements, post-market surveillance, and future regulatory challenges.
Vaclav did support our journey to become ISO 13485 certified with relentless work put into great processes, great communication and detailed and to the point conversations with the teams, individual members - but also our external auditors. He was of great support to move our QMS to the next level. He was the key person behind the move away from paper / scan based documents towards a digital setup.If you are in need for a structured person with great communication skills, a good understanding of the regulatory environment, I can only recommend to reach out to Vaclav. Lucky you if he's not booked ;-) Besides all the success he's an enjoyable and humble character. Great experience to having worked with him.
I had the pleasure to work with Vaclav on Software as Medical Device processes topics, and can only recommend him! It is not only that he has a very high and reliable knowledge in the medical domain, the regulatory domain and the software one, but also that whatever he approaches, he does it in a reasonable and clever way, taking into account the big picture and the real expectations from authorities and the goals of the organisation. With a good internal sponsor to support him, he delivers on his promises very efficiently, and collaborates in a great way, relying on his very good communication skills!
Ensure complete MDR, FDA, IEC 62304, ISO 14971, and cybersecurity compliance.
We understand the regulatory environment. We have experience in implementing all standards related to medical software development, cybersecurity, and technical documentation, and we would be happy to demonstrate in practice how we can translate this expertise into real-world solutions while working on your medical device software product - as a developers a project managers.
Implement ISO 13485-compliant processes using Jira, Confluence, and SharePoint.
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge automation tools. Our expertise spans Microsoft SharePoint, Power Platform, Confluence, Jira, and custom-built solutions tailored to specific needs.
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