Dennis Sandkühler, PhD

Dennis Sandkühler is responsible for quality management at Digital Life Sciences GmbH. He is responsible for the introduction of GxP-relevant software solutions and computer system validation in customer projects. Previously, he worked in the development and regulatory affairs for medical devices. Dennis Sandkühler is a member of the ISPE D/A/CH and author of numerous technical publications.

During his engineering studies in medical technology and PhD in applied mathematics and computer science, Dennis Sandkühler began his professional career with the development of software for medical imaging. In his further career, he developed market-ready medical devices and was co-responsible for the approval in the international market through the qualification as Manager Regulatory Affairs International.

Through his certification as a Project Management Professional (PMI), Dennis Sandkühler has a high level of project competence, which he brings to his current work at Digital Life Sciences GmbH. The focus of Digital Life Sciences GmbH is on software solutions for production-accompanying documentation of manufacturing and quality management.

Dennis Sandkühler has managed numerous international projects for the introduction of software systems in the medical technology sector, laboratory facilities and the pharmaceutical industry and advises and supports companies in computer system validation.

He is author or co-author of the following chapters of GMP Compliance Adviser:

9.B Regulatory requirements for computerised systems and the validation process
9.D System classification and risk management
9.E Qualification and validation of computerised system

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