About us

We are a specialized consulting company servicing the Pharma and Medtech industry in their development of safe,secure and sustainable medical devices and combination products. We focus on making your products ready for approval in the EU, US and rest of the World by delivering end-to-end regulatory compliance, QMS and technical documentation consulting services for your device or combination product.

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Swiss-based company founded in 2012

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Global experts in medical devices and combination products

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Former Notified Body team members and industry experts

Part of Consultys group since 2021

Our management team

Carsten Mueller

CEO

Corinna Kehrle

Packaging Development

Ortzi Olasolo

Medical Devices / Combination Products

Francisca Mucientes

IVD & PM  

Martin Vogel

Human Factors Engineering

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