Medical Device Software
Enabling Your Ideas
All You Need
to launch your Medical Device Software
ISO 13485
Quality Management System
We will set up your Quality Management System in a way that your company benefits from.
Simple, automated and digitised.
IEC 62304
Medical Device Software
Your developers will get confidence that they focus only on things that matter and leave superfluous work behind.
MDR 2017/745
Medical Device Regulation
Our target-oriented approach will get your product to successful Medical Device CE certification in the shortest possible way.
You Are Not Alone
boost development
with external support
We will support your development team in building regulatory-compliant Medical Device Software.
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Applied Technologies
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React / Next.js
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Kotlin Multiplatform
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Java / Spring Boot
We will guide your team through all phases and tasks of the medical device lifecycle. Efficient and regulatory compliant with MDR 2017/745.
Nice To Meet You
Hi, I'm Vaclav, a medical doctor with over 15 years of experience in the world of software.
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I've assisted various companies in building their Quality Management Systems from the ground up and obtaining CE Certification for their Medical Device Software.
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I have collaborated on medical device development with renowned companies such as:
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Novartis
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Roche
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Merck
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Ypsomed
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Together with my team, consultants and developers, we help companies succeed in the medical device industry.
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Why To Work With Us
driven by responsibility
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Multiple successful
ISO and CE certifications
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Experience with giants of the pharmaceutical industry
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Proven experience with the medical field and software development
Satisfaction
Testimonials
Michael Maretzke
CTO, Temedica
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.
David Genoux,
Risk Management, Merck
I had the pleasure to work with Vaclav during our development of a medical product for Merck. I found Vaclav to be very professional and dedicated. His attention to detail and his technical /medical knowledge brought immense valuable inputs to the project. Collaborate with Vaclav was really a pleasure and I warmly recommend him.
Kapil Lokhande,
CTO, Börm Bruckmeier Infotech
Vaclav and I worked closely together for more than 1 year rolling out a SaMD, and I was constantly amazed not only by his technical project management skills, but also by his ability to keep the team motivated through the inevitable challenges. I have been consistently impressed with Vaclav's attitude and productivity during the time I worked with him. Vaclav has shown immense dependability while dealing with teams all across the organisation and facilitated the processes outputs to reach to conclusions and success of the projects. For any company or team that needs a proven PM, SaMD expert with a get-it-done-with-a-quality approach, Vaclav is your guy.