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.
Swiss-based company founded in 2012
Global experts in medical devices and combination products
Former Notified Body team members and industry experts
Part of Consultys group since 2021
CEO
Packaging Development
Medical Devices / Combination Products
IVD & PM
Human Factors Engineering