Home

medsoto_startseite

"Audit-proof" software
and Hardware development.

Managing Compliance
and Efficiency

medsoto_startseite

Software und Hardware
"auditsicher" entwickeln.

Managing Compliance
and Efficiency

We accompany you safely and efficiently through your development and processes

We see ourselves as a solution provider for medical devices. With our tools and the associated consulting, we optimize your development as well as processes throughout the company and accompany you to your audit-proof documentation.

Our medical device experts are at your side from the outset and together with you they will find the optimal solution to implement our tools and Polarion ALM efficiently in your company.

MedPack

MedPack works in conjunction with Polarion ALM (Application Lifecycle Management) to reach a complete solution to developing medical software quickly and in compliance with IEC 62304.

more

RiskPack

Document according to ISO 14971 specifications – without any extra expense. Compile your risk management files comfortably and audit-proof with the RiskPack.

more

DocuPack

DocuPack is a complete solution to maintain and manage your regulatory documentation for medical devices.

Please contact us for more information