Carlos Carvalho

The #NotifiedBody plays a central role in the process of becoming a medical device manufacturer. We spoke to Dietmar Schaffarczyk, auditor at QS Schaffhausen AG, to find out more about what the NB expects from young #MedTech startups.   Our key takeaways: ◾ NBs must maintain their independence in their assessments, which is why they must not offer direct advice. ◾ While each company must be compliant, NBs take into account the current status of a company. ◾ Long-term success can only be guaranteed by building internal expertise in addition to external support. ◾ When you first contact an NB for a QMS audit, for example, 65% of the documentation should be ready. Read the full interview here 👉 https://lnkd.in/gTvz9a5e

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🎉 It's only been a week and it still feels unreal! Relive with us the MDR certification ceremony for Medical Devices by TÜV SÜD 🏅.  ⬇️   We are proud to announce that DEKA M.E.L.A. is among the first companies in the world to receive the new MDR certification for Medical Devices from TÜV SÜD. This achievement allows us to continue investing in research and technological innovation in Europe. For companies like DEKA that manufacture in Italy, the challenges are numerous and crucial. Regulatory and certifying bodies ensure the safety of products and methodologies: there are no compromises when it comes to technology applied to medicine! Thanks to the MDR certification, we can develop even safer and more effective medical laser systems for applications in dermatology, surgery, aesthetic medicine, and much more.   But it doesn't end here! The new certification (Annex XVI of Regulation EU 745/2017) offers us an extraordinary competitive advantage! Now we can introduce new products and make changes to existing ones with unprecedented speed and flexibility 🚀.   #DEKALaser #OnlyByDEKA #MDRcertification #Innovation #MedicalInnovation #HealthcareTech #MedicalDevice

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#MedicalDevices approval in China Basic information on classifying and submitting your medical device to the NMPA. Read more about this in our latest blog post 🔍 #regulatoryaffairs #medicaldevices #qualityassurance #healthcare #medizintechnik #seleon

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🔍 Navigating the Waves of MDR Regulations in Medical Technology 🔍 The MDR (Medical Device Regulation) is shaping the future of Lumetry Diagnostics and many other companies in the medical technology sector. We collaborate closely with experts like Tibor Zechmeister to navigate the challenges posed by MDR and ensure patient safety. If you have a subscription to ÖKZ, Austria's leading magazine for healthcare professionals, you can read about the impact of MDR on both small and large companies. We are committed to meeting these requirements as we continue to innovate and improve people's quality of life. 📖 Read the full article here: https://lnkd.in/dFErmDi6 #HealthTech #MedTech #MDRRegulation #PatientSafety #MedicalDevice #ÖKZ #LumetryDiagnostics #LungHealth

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Learn how ZEISS Microscopy can contribute to a circular battery economy. Watch on-demand now 👉 https://lnkd.in/eq6HMwxK #batteries #microscopy #energytransition #sustainability

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🤖 Robotics, AI und 3D printing are some of the exciting topics #rehacare2024. 👉 Hannes Niemann, Director of REHACARE, tells you what you shouldn't miss here!

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