On the pulse of the industry
Notified bodies, authorities, industry associations – we have a direct line to all stakeholders. This is how we open doors to the right contacts and access to valid, first-hand information.
Consulting
Regulatory affairs and quality management for medical devices and in vitro diagnostics. Looking for professional support for ISO 13485, MDSAP, audits, risk management, gap assessment MDR/IVDR, technical documentation?
With us you get individual support and customized consulting!
Academy
Practice-oriented training for medical devices and in-vitro diagnostics: in-house and public – presence and ONLINE! From individual seminars to our online course: REGULATORY EXPERT to MBA Health Tech Management. Outsourcing of your training activities. For beginners and advanced!
A high performance network
Together we can move mountains. Should we not be able to cover your needs or only partially, we will be happy to recommend our long-standing cooperation partners.
Our Team
We have been passionately serving our customers and the industry for over 20 years!
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Newsletter
All essential changes & really relevant news in regulatory affairs and quality management for medical devices & in-vitro diagnostics:
Clearly summarized by our experts and the effects clearly presented for you!
Downloads
Practical guide for medical device software manufacturers:
Basic questions on the scope and start of the EU Medical Device Regulations MDR / IVDR and their significance for affected software companies. Incl. practical examples for delimitation and classification of medical device software.
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Christa Bachinger-Hauk2025-10-01 16:17:532025-10-01 16:17:53Presentation materials: Regulatory Update: Sustainability, DiGA, Safety vs. Security, UDI, and EUDAMED from May 21, 2025
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Christa Bachinger-Hauk2025-10-01 15:59:232025-10-01 15:59:23Free basic check ISO 13485: Quality management for medical devices and IVD
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Christa Bachinger-Hauk
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Christa Bachinger-Hauk2025-10-01 15:53:102025-10-01 15:53:10Presentation materials: Regulatory Update: EU AI Act, ISO 13485, ISO 14971, EUDAMED, IEC 62304, DeepTech funding, and MDR best practices from September 22, 2025
