Evnia

Evnia was founded in 2015 in #Copenhagen with the vision to become the missing link between manufacturers, regulators and investors coworking for the time-effective commercialization of innovative #medicaldevices and #invitrodiagnostics. Headquartered in #Denmark, the company current has offices in the #UK, #Greece, #Switzerland and #Italy and is servicing life-science clients globally. It has been certified under ISO 9001:2015 as a Clinical and #regulatoryaffairs #consultingagency within the life science industry. Evnia offers a cluster of interconnected services from the early stages of a medical device’s lifecycle until its post-market adulthood. We support #healthcareinnovation and promotion of #patientsafety by providing services in the fields of  📌 Due Diligence  📌 Regulatory Strategy  📌Clinical Development Strategy 📌 Post-Market Surveillance 📌 Real World Evidence 📌 Market Access and Reimbursement 📌 #EU and #UK Representation Services (#AuthorisedRepresentative & #UKCA #UKRP) Our full-value-chain services are supported by a growing, cross-functional team of #medicalwriters, medical doctors, #engineers for #usability, risk and validation, #biostatisticians, #biocompatibility experts and regulatory affairs executives. Our in-house human resources enable the development and implementation of holistic approaches covering the entire lifetime of medical products. Reach out for an introductory discussion! #medtechnews #medicaltechnology #medtech #postmarketsurveillance #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #RWE #RWD #registries #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #clinicaldevelopment #PMCF Efstathios Vassiliadis Julie Moore Graphic Design by isotopon and Panos Arkomanis

#medtechnews #medtech #medicaldevices #invitrodiagnostics #biotech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #cemark #cemarking #marquageCE

Swissmedic has updated its Guidance for the requirements of the Responsible Person. 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝘁𝗼 𝘁𝗵𝗲 𝗽𝗿𝗲𝘃𝗶𝗼𝘂𝘀 𝘃𝗲𝗿𝘀𝗶𝗼𝗻 📍Whole text: checking and corrections of legal references. Editorial improvements 📍 Chapter 2: listing of the MPLO articles suppressed (redundancy with chapter 1 and 4); addition of reference to Guidance on good manufacturing practices, Good manufacturing practices for small quantities, Ph. Helv., and good distribution practice, Question and answer by the EMA 📍 Chapter 3: addition of the definition of EMA and Ph. Helv., reference to MPLO deleted 📍 Chapter 5.1: precisions about required education and knowledges 📍 Chapter 5.2: precisions about activities were #GDP and/or #GMP experience are required. The experience with regulatory issues as acceptable criterium has been removed. Precision about the experience required for an area with specific risks. Precision, that brokerage, agents, trade in foreign countries-activities do not count as GDP experience 📍 Chapter 5.4: Executive board corrected with company’s management, board of director corrected with supervisory committee 📍 Chapter 5.5: precisions about the RP language requirements. The Responsible Person is proficient in one of the official local languages of the canton where the licensed site is located. A 12-month grace period has been granted for establishment license holders whose RPs do not already fulfill this requirement. 📍 Chapter 5.6: precision about the understanding of what is the direct supervision of a facility 📍 Chapter 5.6.1: new chapter about remote technical and market release 📍Chapter 5.6.2: chapter subject changed from part-time RP (now moved to chapter 5.6.4) to presence on site. Addition of precisions about the expected presence on site of the RPs. Precision of conditions permitting a reduction of physical presence on site. Precision about the cases where an intensified presence on site is expected. 📍 Chapter 5.6.3: new chapter about pensum of the RPs. 📍 Chapter 6: precision, that the same requirements apply for the deputy RP as for the RP, inclusive domicile. Deputies RP are not checked by Swissmedic in the context of licence applications 📍 Chapter 7: precisions about possibilities and conditions for tasks delegation. Precisions about critical processes and release activities 📍Chapter 8: precisions regarding the absence of the RP #medtech #medicaldevices #Switzerland #swissmedtech

#LeSaviezvous? L’INSERM a lancé en 2022 l'initiative #VolREthics pour aborder les questions éthiques concernant la participation des #volontairessains à la #recherchebiomédicale. Soutenue par des partenaires internationaux, elle vise à partager et discuter des pratiques pour mieux protéger ces volontaires. 𝗘𝗻 𝗷𝘂𝗶𝗻 𝟮𝟬𝟮𝟰, 𝘂𝗻𝗲 𝗖𝗵𝗮𝗿𝘁𝗲 𝗲𝘁𝗵𝗶𝗾𝘂𝗲 𝗺𝗼𝗻𝗱𝗶𝗮𝗹𝗲 𝗮 𝗲𝘁𝗲 𝗽𝘂𝗯𝗹𝗶𝗲𝗲 𝗽𝗼𝘂𝗿 𝗴𝘂𝗶𝗱𝗲𝗿 𝗰𝗲𝘁𝘁𝗲 𝗽𝗿𝗼𝘁𝗲𝗰𝘁𝗶𝗼𝗻 𝗱𝗮𝗻𝘀 𝗹𝗲𝘀 #𝗲𝘀𝘀𝗮𝗶𝘀𝗰𝗹𝗶𝗻𝗶𝗾𝘂𝗲𝘀. Texte intégral: https://lnkd.in/gNWEncVP #Didyouknow #France's National Institute of Health and Medical Research #INSERM launched the #VolREthics initiative in 2022 to address ethical questions regarding the participation of #healthyvolunteers in #biomedicalresearch. Supported by international partners, it aims to share and discuss practices to protect healthy volunteers. 𝗪𝗶𝘁𝗵𝗶𝗻 𝘁𝗵𝗶𝘀 𝗰𝗼𝗻𝘁𝗲𝘅𝘁, 𝘁𝗵𝗲 𝗚𝗹𝗼𝗯𝗮𝗹 𝗘𝘁𝗵𝗶𝗰𝘀 𝗖𝗵𝗮𝗿𝘁𝗲𝗿 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗣𝗿𝗼𝘁𝗲𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵𝘆 𝗩𝗼𝗹𝘂𝗻𝘁𝗲𝗲𝗿𝘀 𝗶𝗻 #𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹𝗧𝗿𝗶𝗮𝗹𝘀 𝘄𝗮𝘀 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗶𝗻 𝗝𝘂𝗻𝗲 𝟮𝟬𝟮𝟰. Read it here: https://lnkd.in/gsekHAHB Read more (available translations in #spanish and #portugese): https://lnkd.in/erqHRYAb #medicalresearch #clinicalresearch #drugdvelopment #clinicalstudies #clinicalinvestigations #goodclinicalpractice #pharma #pharmaindustry #biotech #medtech

🌟 Did you know that graphene is 1 million times thinner than a human hair but stronger than steel and diamond? 💎 Thanks to #EUFunded research, this material has moved from the lab to industry, boosting the economy, creating jobs, and positioning Europe as a leader in cutting-edge technology. 🚀 The 2D-BioPAD project aims to provide a fast and cost-effective system for early Alzheimer's diagnosis using graphene-based sensors, aptamers, nanoparticles, microfluidics, and AI. 🔬 Learn more about graphene here ➡️ https://lnkd.in/dcGxEAEy #2dbiopadproject #horizoneurope #alzheimerdisease #innovation #graphene #nanomaterials #IVD #invitrodiagnostics Palacký University in Olomouc | Czech Advanced Technology and Research Institute | RCPTM - Regional Centre of Advanced Technologies and Materials | Q-PLAN INTERNATIONAL | Institut Català de Nanociència i Nanotecnologia (ICN2) | Grapheal | Aristotle University of Thessaloniki (AUTH) | NOVAPTECH | University of Eastern Finland | Alzheimer Hellas (Greek Association of Alzheimer’s Disease and Related Disorders) | Evnia | Central Institute of Mental Health | CeADAR Ireland | Graphene Flagship

#Didyouknow The European Commission has designated five European laboratories as #EuropeanUnion reference laboratories #EURLs for high-risk #invitrodiagnostics acc. to Art 100 of #IVDR? The scope of the class D devices covered by the EURLs includes ➡️#Hepatitis and #retroviruses ➡️#Herpes viruses ➡️Bacterial agents ➡️Respiratory viruses that cause life-threatening diseases The scope covered by each individual EURL can be found here: https://lnkd.in/gFKt8xKj The five labs are: 📍Paul-Ehrlich-Institut, #Germany 📍RISE Research Institutes of Sweden #Sweden 📍CQS (Consulting Químico Sanitario) #Spain 📍Instituto de Salud Carlos III, Spain 📍Consortium, Servicio madrileño de salud (SERMAS) ), composed of 3 hospitals in #Madrid, Spain: ✔️Hospital General Universitario Gregorio Marañón ✔️Hospital Universitario la Paz ✔️Hospital Universitario Ramón y Cajal #medtech #biotech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #medicaldevices #cemark #cemarking #EVNIA_AR

#Didyouknow The Medicines and Healthcare products Regulatory Agency offers a pre-submission service before applying for #medicines Marketing Authorisations? Companies who intending to submit #MarketingAuthorisation Applications for New Active Substances and/or #Biologicalproducts must request a pre-submission meeting with the relevant teams at least 3 months prior to the intended application date. Read more: https://lnkd.in/e8D3w_Mm #pharma #pharmanews #drugdevelopment #UK #regulatoryafairs

#Didyouknow 📢The Phase 2 Evaluation support study on #HorizonEurope's contribution to a resilient #Europe has been published It is an input into the interim evaluation of Horizon Europe, covering the period 2021-2023. The scope of the study covers three Clusters of Horizon Europe Pillar II: 1) Cluster 1: Health 2) Cluster 2: Culture, Creativity, and Inclusive Society 3) Cluster 3: Civil Security for Society Additionally, it encompasses the #Cancer Mission and several key partnerships, including the Second Innovative Medicines Initiative (IMI2), Innovative Health Initiative Joint Undertaking (IHI), and EIT Health, among others. #fundingprogrammes #scientificresearch #technologicaldevelpoment #innovation #sustainability

Sport 'n' Charity was founded in 2022 in #Denmark after its founders Martin and Frederik, found out the results of a project from Rigshospitalet demonstrating the benefits of physical exercise for cancer patients during and after treatment. The research demonstrated that patients who exercise, reduce significantly the risk of developing further diseases and disabilities. After consulting with the researchers, they decided to establish an association that would offer training sessions to children with #cancer, helping them to regain physical strength. Children with cancer have to overcome difficulties beyond their years. Sport 'n' Charity’s training programs, focusing on strength, balance, coordination, fine and gross motor skills, sensory stimulation and endurance, help them to reclaim their lives by giving them back control of their bodies and physical abilities. We are proud to support an organisation, which makes such a positive difference in children’s health and well-being, and we would like to invite you to join us in supporting their remarkable work. #corporateresponsibility #ToStriveToSeekToFind #Evnia_Filotimo #Evnia_CSR

#Friday_Evnia_Treats We have summarised the deadlines associated with the Regulation (EU) 2024/1860 amending #IVDR ! #Remember 𝗧𝗵𝗲 𝗰𝗵𝗮𝗻𝗴𝗲 𝗼𝗳 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻𝘀 𝗼𝗻𝗹𝘆 𝗮𝗽𝗽𝗹𝗶𝗲𝘀 𝘁𝗼 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗿𝗲𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝗺𝗲𝗻𝘁 𝗼𝗳 𝗮 𝗻𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗯𝗼𝗱𝘆 The deadlines have been extended provided that the manufacturer: 📌 has implemented and maintains an IVDR-compliant #QualityManagementSystem 📌 has lodged a formal application for certification within the applicable dates per risk class 📌 has signed a contract with the #notifiedbodybefore the date applicable to the risk class of the device. In addition, the devices: 📌 must continue to comply with the Directive requirements; 📌 cannot undergo any significant change in the design or intended purpose; 📌 must not present an unacceptable risk to the health or safety of patients, and/or users. Read more: https://lnkd.in/deyX6U76 🔊 Evnia's tip: ❗⛔❗ Do not put an halt in your remediation process! Instead, 👉 identify gaps in your #verification program and pools of #clinicaldata 👉 determine the sufficiency of your #clinicalevidence 👉 plan and commit to realistic #PMCF activities 👉 triple-check the consistency of statements across your #TechnicalDocumentation #medtech #biotech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #medicaldevices #companiondiagnostics #IVDR #invitrodiagnostics #cemark #cemarking #EVNIA_AR