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Software & (IVD) Medical Devices with AI  
We help you to efficiently develop and successfully approve your software medical devices and IVD software – including AI-based medical devices.  
AI Act Compliance Fast Track  
Integrating AI into your medical devices opens up revolutionary possibilities – but it also brings with it complex regulatory challenges that can trip up even experienced development teams. …  
Market Access & Regulatory Affairs  
We help you gain access in all markets worldwide with your medical and IVD medical devices and make the right strategic decisions in regulatory affairs.  
US Market Access  
Bring your medical and IVD medical devices to market in the USA in just a few months through the 510(k) or De Novo Procedure.  
IT Security Testing  
Our effective and IEC 81001-5-1 compliant pen tests help you quickly and safely bring your medical and software devices to market.  
Product Testing  
We help you to carry out the required tests, studies, and investigations for your medical and IVD medical devices in the most efficient and legally compliant manner possible.  
IT Security  
Quickly and safely pass approval, audits, and reviews with legally compliant cybersecurity files and IT-secure devices.  
Get to know your trainer  
Dimitrios Kaloulis supports customers in outsourcing regulatory roles: Management Representative according to ISO 13485, Authorized Representative and Responsible Person according to MDR. He…  
Are in-house IVDs (IH-IVDs) the same as laboratory-developed tests (LDTs)?  
Are in-house IVDs (IH-IVDs) the same as laboratory-developed tests (LDTs)? ‘In-house IVD’ and ‘LDT’ are often used in similar contexts or even as synonyms. However, the terms are not automatically…  
Which IVDR requirements apply to an in-house IVD?  
Which IVDR requirements apply to an in-house IVD? Healthcare organisations must check for each in-house IVD whether it meets the requirements set out in Article 5(5) of the IVDR. These include,…  
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