Evnia

𝗘𝘃𝗻𝗶𝗮 𝗶𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗲𝘀 𝗮 𝗽𝗮𝗿𝗮𝗱𝗶𝗴𝗺 𝘀𝗵𝗶𝗳𝘁 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗲𝗱𝘁𝗲𝗰𝗵 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗯𝘆 𝗼𝗳𝗳𝗲𝗿𝗶𝗻𝗴 𝗲𝘅𝗽𝗲𝗿𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀. We support manufacturers throughout the medical device development roadmap. From the early concept and design stages to verification and validation, until market access and post-market adulthood, 𝗘𝘃𝗻𝗶𝗮 𝗲𝗻𝗮𝗯𝗹𝗲𝘀 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗲𝗻𝘀𝘂𝗿𝗲𝘀 𝗮𝘂𝗱𝗶𝘁 𝗮𝗻𝗱 𝗶𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀. Founded in 2015 in #Copenhagen, Evnia has become 𝘁𝗵𝗲 𝗺𝗶𝘀𝘀𝗶𝗻𝗴 𝗹𝗶𝗻𝗸 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀, 𝗮𝗻𝗱 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀 working for #healthcareinnovation and the improvement of patients quality of care and life. Our know-how and cluster of interconnected services brings to the table 𝗮 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲, 𝘁𝗶𝗺𝗲- 𝗮𝗻𝗱 𝗰𝗼𝘀𝘁-𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝘀𝗲𝗿𝘃𝗶𝗰𝗲. A 𝗼𝗻𝗲-𝘀𝘁𝗼𝗽-𝘀𝗵𝗼𝗽 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝘁𝗼 𝗮𝗱𝗱𝗿𝗲𝘀𝘀 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗮𝗻𝗱 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗻𝗲𝗲𝗱𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵𝗼𝘂𝘁 𝘁𝗵𝗲 𝗹𝗶𝗳𝗲𝘁𝗶𝗺𝗲 𝗼𝗳 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 or an #invitrodiagnostic.   📌 Due Diligence 📌 Regulatory Strategy 📌Clinical Development Strategy 📌Quality Management System 📌Technical Documentation 📌Clinical Evaluation 📌 Post-Market Surveillance  📌 Clinical Data & Real World Evidence 📌 Market Access and Reimbursement 📌 #EU and #UK Representation Services (#AuthorisedRepresentative &  #UKCA #UKRP) Browse our new brochure and reach out for an introductory discussion! https://lnkd.in/dGXk8qCy 📍Evnia Clinics Network: https://lnkd.in/d42y2YBg 📍 EVA Algorithm: https://lnkd.in/d8c-HcVb We strive, We seek, We find.  We are Evnia! #medtechnews #biotechnews #medtech #biotech #qualitymanagement #qualitymanagementsystem #riskmanagement #technicaldocumentation #notifiedbodies #postmarketsurveillance #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #clinicaldevelopment #PMCF #fdacompliance #UKCAmark #regulatoryaffairs Efstathios Vassiliadis

Evnia proudly announces that our CEO Dr. Efstathios Vassiliadis will be speaking at the #Riyadh Global Medical Biotechnology Summit RGMBS 2024, held in the KSA’s capital from 10-12 November. https://lnkd.in/dWvyfYik As an organisation, we prioritise healthcare innovation and actively working for the timely market access of medical products, which aim to address unmet needs and healthcare deficiencies in emerging and developed regions. Within this context, building an ecosystem of #biotechnology #startups is essential to shaping proactive, preventive healthcare and state-of-the-art #diagnostics and #therapeutics. Being part of the RGMBS Summit and exchanging experiences and views with esteemed researchers, #healthcareprofessionals, policymakers, and entrepreneurs is part of our vision to bridge the gaps between basic research, authorities, and #investors! Join us! The event will be available via live streaming: https://lnkd.in/dWvyfYik #biotech #biotechnews #MiddleEast #SaudiArabia #startupcommunity

An important update has been released by the Medicines and Healthcare products Regulatory Agency regarding the changes to #UK #MarketingAuthorisations starting from January 2025. These changes include: 📌 Centralised authorisations will no longer apply in #NorthernIreland 📌 Existing #GreatBritain authorisations will have effect across the whole of the UK. 📌 Holders of GB and NI authorisations for the same product must have surrendered their NI authorisation by 30 September 2024 a single UK authorisation will be the standard for new and innovative drugs. 📌There may be some circumstances where that does not apply Read more: https://lnkd.in/ec5D-3-U #pharma #pharmaindustry #brexit #pharmanews

Sponsors of pre-market #clinicalinvestigations for #medicaldevices are invited to participate in an online survey conducted as part of the Harmonised Approach to Early Feasibility Studies for Medical Devices of the  HEU-EFS project. Funded by the Innovative Health Initiative (IHI), the HEU-EFS project aims to develop a standardized methodology and set recommendations to streamline #EarlyFeasibilityStudies within the #EU. 🔗Take the survey and contribute with your input in developing a robust EFS framework for Medical Devices! https://lnkd.in/eUxJ-Awt The results will be presented in a dedicated webinar on the project website: https://heuefs.eu/. MedTech Europe EFPIA - European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio - the European Association for Bioindustries Vaccines Europe #EvidenceGeneration #Regulatoryaffairs #ClinicalTrials #clinicalresearch #medtech #medtechnews #pharma #pharmanews

𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗯𝘆 𝗘𝘃𝗻𝗶𝗮 : 𝘁𝗵𝗲 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗼𝗳 𝗚𝗲𝗻𝗲𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗼𝗳 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗘𝘃𝗶𝗱𝗲𝗻𝗰𝗲 #Didyouknow Evnia offers a comprehensive RWE program including 📍Patient and Device Registries 📍 Surveys 📍 Clinical Experience Data 📍 Observational Studies which can support the body of evidence for your #medicaldevices or #invitrodiagnostics throughout their lifecycle? Read more: https://lnkd.in/dYvYRmiT If you are looking for optimised lifecycle management activities and to maximise your post-approval market status, we have the right program! Let our team of experts accommodate your quality and regulatory journey! Efstathios Vassiliadis #medtech #medtechnews #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs #internationalregulatoryaffairs #notifiedbodies #cemark #cemarking #startups #fdacompliance https://lnkd.in/dBcJUbb9

#Savethedate After launching the new #clinicaltrials guidance, https://lnkd.in/gjtMXmXt the World Health Organization WHO and The Global Health Network are hosting a webinar to discuss it 📅 13 December at 13:00 GMT 🔗https://lnkd.in/dQcuKypE Speakers: Dr Jeremy Farrar, WHO Chief Scientist Dr Vasee Moorthy, WHO Senior Advisor, Research for Health #clinicaresearch #clinicalstudies #clinicaltrials

#Remember Τhe FDA is hosting the inaugural Digital Health Advisory Committee meeting on November 20-21, 2024 to discuss 👉total product lifecycle considerations for generative #artificialintelligence (AI)-enabled #medicaldevices; 👉how the use of generative AI-may impact safety and effectiveness of medical devices enabled with this technology; and 👉premarket performance evaluation, #riskmanagement, and postmarket performance monitoring for generative AI-enabled devices. Read more: https://lnkd.in/dAjUaDk6 Webcast Information 📌November 20, 2024 YouTube: https://lnkd.in/dEDUD_89 Link Disclaimer 📌 November 21, 2024 YouTube: https://lnkd.in/dZXvRvkR #medtech #medtechnews #artificialintelligenceinhealthcare

#Didyouknow The #CIOMS Glossary of ICH terms and definitions is now freely available for download on the CIOMS website! https://lnkd.in/ePbVv2UF The glossary includes definitions from the following ICH guidelines: 📌Paediatric Extrapolation. Step 4, Aug 2024. 📌M13A. Bioequivalence for Immediate-Release Solid Oral Dosage Forms. Step 4, Jul 2024. 📌Q4B(R1). Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Final version, Jun 2024. #clinicalresearch #drugdevelopment #pharmaceuticals #pharmaindustry

𝗘𝘃𝗻𝗶𝗮 𝗶𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗲𝘀 𝗮 𝗽𝗮𝗿𝗮𝗱𝗶𝗴𝗺 𝘀𝗵𝗶𝗳𝘁 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗲𝗱𝘁𝗲𝗰𝗵 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗯𝘆 𝗼𝗳𝗳𝗲𝗿𝗶𝗻𝗴 𝗲𝘅𝗽𝗲𝗿𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀. We support manufacturers throughout the medical device development roadmap. From the early concept and design stages to verification and validation, until market access and post-market adulthood, Evnia 𝗲𝗻𝗮𝗯𝗹𝗲𝘀 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗲𝗻𝘀𝘂𝗿𝗲𝘀 𝗮𝘂𝗱𝗶𝘁 𝗮𝗻𝗱 𝗶𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀. Founded in 2015 in #Copenhagen, Evnia has become 𝘁𝗵𝗲 𝗺𝗶𝘀𝘀𝗶𝗻𝗴 𝗹𝗶𝗻𝗸 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀, 𝗮𝗻𝗱 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀 working for #healthcareinnovation and the improvement of patients quality of care and life. Our know-how and cluster of interconnected services brings to the table 𝗮 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲, 𝘁𝗶𝗺𝗲- 𝗮𝗻𝗱 𝗰𝗼𝘀𝘁-𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝘀𝗲𝗿𝘃𝗶𝗰𝗲. A 𝗼𝗻𝗲-𝘀𝘁𝗼𝗽-𝘀𝗵𝗼𝗽 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝘁𝗼 𝗮𝗱𝗱𝗿𝗲𝘀𝘀 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗮𝗻𝗱 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗻𝗲𝗲𝗱𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵𝗼𝘂𝘁 𝘁𝗵𝗲 𝗹𝗶𝗳𝗲𝘁𝗶𝗺𝗲 𝗼𝗳 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 or an #invitrodiagnostic. 📌 Due Diligence 📌 Regulatory Strategy 📌Clinical Development Strategy 📌Quality Management System 📌Technical Documentation 📌Clinical Evaluation 📌 Post-Market Surveillance 📌 Clinical Data & Real World Evidence 📌 Market Access and Reimbursement 📌#EU and #UK Representation Services (#AuthorisedRepresentative & #UKCA #UKRP) Browse our new brochure and reach out for an introductory discussion! https://lnkd.in/dGXk8qCy 📍Evnia Clinics Network: https://lnkd.in/d42y2YBg 📍 EVA Algorithm: https://lnkd.in/d8c-HcVb We strive, We seek, We find. We are Evnia! #medtechnews #biotechnews #medtech #biotech #qualitymanagement #qualitymanagementsystem #riskmanagement #technicaldocumentation #notifiedbodies #postmarketsurveillance #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #PMCF #fdacompliance #regulatoryaffairs Efstathios Vassiliadis

𝗜𝘁'𝘀 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝘄𝗼𝗻𝗱𝗲𝗿𝗳𝘂𝗹 𝘁𝗶𝗺𝗲 𝗼𝗳 𝘁𝗵𝗲 ...𝗳𝗲𝗮𝗿!! And we are very excited to be publishing Evnia's October newsletter this #Halloween day! Wishing everyone a scarytale reading! We hope you ‘’ll enjoy this newsletter’s (special) decorations !! #medtechnews #postmarketsurveillance #riskmanagement #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #RWE #RWD #registries #surveys #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #clinicaldevelopment #PMCF #corporategoals Efstathios Vassiliadis Katerina Slouka https://lnkd.in/etZWUBAr