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Airon Telematica, an Italian publisher of clinical research software, works with hospitals around the world. To launch projects with French institutions, the company needed to obtain HDS certification. It achieved this certification across all six areas of the standard.
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Airon Telematica is developing a platform on which hospitals and clinicians can enter their patients' data for clinical research. Its projects involve institutions around the world.
New projects with French hospitals made HDS certification essential. For a small non-French company, the challenge was twofold: understanding the technical, legal, and contractual requirements specific to France, in addition to the ISO 27001 certification already in place.
After comparing several firms, Airon Telematica chose us because of our personalized approach. Our project manager used the existing management system as a starting point to pinpoint the HDS gaps.
Analysis of the gaps between the existing management system and the HDS requirements.
Action plan with clear steps and deadlines. HDS measures
A one-day audit of the six HDS activities, with no major nonconformities.
We’ll guide you through the HDS certification process, whether you’re in France or abroad.
