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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?
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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.
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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!
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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