Medical Device SoftwareDevelopment & Consulting

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.

Vaclav and I worked together on risk management activities of medical device development projects. His ability to quickly grasp the challenges and to accomplish a task/project is remarkable. Additionally, his ability to propose and develop software solutions to improve projects’ efficiency is commendable. I find Vaclav to be flexible, dependable, and quality centric. Hence, I really enjoyed working with Vaclav and looking forward to associate with him again.

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 devoted. 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.

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!

Vaclav was for our company an immense help in the process of getting ISO 13485 certified. He set up lots of QMS relevant documents, implemented a project management system in our company to support the sprints, the ticketing system and the overall documentation and gave always valuable input for all questions which arised in the long certification process. Vaclav is a very reliable, friendly person with excellent knowledge in medical, technical and regulatory fields.I liked his humour a lot, especially in tensed situations he was able to smooth out waves of stress.His structured way of working and his communications skills helped a lot to move ahead with all involved stakeholders - no matter if international programming team, auditors or clients.I would love to work with him again and envy anyone who will - lucky you!

Bei Ypsomed hat Vaclav in meinem Risk Management Team einen wertvollen Beitrag geleistet und unsere Arbeiten vorangebracht. Seine umfassende Expertise haben wir im Team sehr geschätzt. Die ihm zugewiesenen Arbeiten hat er selbstständig und zu unserer vollen Zufriedenheit erledigt. Besonders erwähnen möchte ich, dass er zu vorhandenen Problemstellungen im Risk Management kreative Lösungsvorschläge aufgrund seiner Erfahrung in der Software Programmierung einbringen konnte. Die Zusammenarbeit mit Vaclav war sehr angenehm. Ich möchte mich bei Vaclav für die tolle Zeit und die geleistete Arbeit bedanken. Vaclav kann daher nur weiterempfehlen.

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.Vaclav is a self-motivated and detailed oriented hard working professional. I highly recommend him and believe he would be a great asset to any organisation.