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
Forskning inden for bioteknologi
København , Capital Region 5.692 følgere
Medical Device & Pharma Compliance, R&D and Investments
Om os
Evnia provides the Medical Device, Pharma and Biotech industries with specialised consulting services in the areas of Regulatory Affairs/Compliance, R&D and Management by transforming data and regulations into measurable actions and tailored solutions. Key know-how and services include: - Clinical Evaluation Reports - Clinical and Technical Documentation - In Vitro Diagnostics (IVDR), Performance evaluation Plans/reports (PEP/PERs) - Regulatory and Project Management and external sourcing activities - Regulatory Compliance for Authorities globally - Clinical Experience Data We serve the Life-Sciences Industry and promote patient care and quality of life by striving, seeking and finding solutions that support compliance and R&D decisions in investments, innovation and medical/regulatory communications.
- Websted
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http://evnia.dk
Eksternt link til Evnia
- Branche
- Forskning inden for bioteknologi
- Virksomhedsstørrelse
- 51-200 medarbejdere
- Hovedkvarter
- København , Capital Region
- Type
- Selvejende
- Grundlagt
- 2015
Beliggenheder
Medarbejdere hos Evnia
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Rianne Tooten
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Chris Busse
Business Development Solutions and Client Focused Services for the Healthcare Industry
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Clive Stone
CEO LCS Professional Services - Chair of Auriga Services - Chair of The Lunar Society - Trustee of Evnia Trust Fund and other Organisations - a…
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Brian Moan
Medical Device Regulatory and Quality Professional
Opdateringer
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Evnia will be attending MEDICA - Leading International Trade Fair on #Dusseldorf from 11-14 November! We would love to connect with you and discuss how we can support your regulatory and clinical journey! Contact us to schedule an onsite meeting! Efstathios Vassiliadis Vicky Valla, Ph.D. Chris Busse #medtechnews #medicaldevices #biotechnews #medtech #biotech #notifiedbodies #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #fdacompliance #regulatoryaffairs
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#Friday_Evnia_Treats The EU-MDR creates significant regulatory challenges for drug-device combination product manufacturers since these products may be regulated either as #medicinalproducts or #medica devices, depending on their primary mode of action. Understanding how to navigate regulatory challenges can have a significant impact on both the strategic planning of a manufacturer/developer and patient safety. In particular, the approval process for manufacturers of integral combination products now requires an opinion from a notified body (NBOp) affirming the conformity of the device part to the applicable General Safety and Performance Requirements (Art. 117). This opinion must be included in the Marketing Authorisation Application submission and is critical to the approval pathway. Article 117 applies to a wide range of products such as #autoinjectors, #inhalers, pre-filled #nebulisers, pre-filled #pens, pre-filled #syringes and #transdermal #patches. Evnia has summarised the types of #combinationproducts and their respective regulatory pathways in a short video. Contact us if you need assistance with your regulatory/clinical journey! #medtech #medtechnews #pharma #pharmanews #technicaldocumentation #notifiedbodies #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #cemark #cemarking #EVNIA_AR #Evnia_UKPR #regulatoryaffairs
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Evnia will be attending MEDICA - Leading International Trade Fair on #Dusseldorf from 11-14 November! We would love to connect with you and discuss how we can support your regulatory and clinical journey! Contact us to schedule an onsite meeting! Efstathios Vassiliadis Vicky Valla, Ph.D. Chris Busse #medtechnews #medicaldevices #biotechnews #medtech #biotech #notifiedbodies #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #cemark #cemarking #digitalhealth #EVNIA_AR #Evnia_UKPR #fdacompliance #regulatoryaffairs
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The FDA has released their final guidance on "#ElectronicSystems, #ElectronicRecords, and #ElectronicSignatures in #ClinicalInvestigations Questions and Answers" to provide The guidance applies to the use of electronic systems in clinical investigations of #medicalproducts, foods, tobacco products, and new #animaldrugs. The Agency 📍updates recommendations for electronic systems deployed by regulated entities in clinical investigations, which are using a risk-based approach for validation 📍 the Agency clarifies that electronic records from #realworlddata sources submitted to FDA as part of a marketing application are subject to Part 11 requirements but the use of data from #ElectronicHealthRecords will not be subject to Part 11 📍provides recommendations regarding #datacollection from #digitalhealthtechnologies used in clinical investigations 📍clarifies recommendations for the use of electronic signatures in clinical investigations. #fdacompliance #medtech #medtechnews #clinicalresearch #digitalhealth
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Intriguing new #artificialintelligence tool developed and validated by the FDA that could enable researchers to efficiently identify and analyze safety-related drug labeling changes: https://lnkd.in/gjUi-RkY This tool is part of BERTox (https://lnkd.in/eUePjp8J), an initiative of the NCTR-developed AI4TOX program (https://lnkd.in/esBC8WAi) that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products. #pharma #pharmanews #artificialintelligenceinhealthcare
Are you interested in AI to support postmarket drug safety research? Check out this publication which discusses a novel AI tool created and validated by FDA that could enable researchers to efficiently identify and analyze safety-related drug labeling changes: https://lnkd.in/gjUi-RkY We envision that the tool can increase efficiency for identifying safety-related labeling changes. This tool is part of BERTox (https://lnkd.in/eUePjp8J), an initiative of the NCTR-developed AI4TOX program (https://lnkd.in/esBC8WAi) that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products. This research was conducted by authors George A. Neyarapally, Leihong Wu, Joshua Xu, Esther H. Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D. Vaughn, Ellen Pinnow, and Hong Fang.
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The Team-NB has issued a press release for the transition of #IVDs class D oversight by EU Reference Laboratories #EURLs. 𝗙𝗿𝗼𝗺 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝘀𝘁 𝟮𝟬𝟮𝟰, 𝘁𝗵𝗲 𝗘𝗨𝗥𝗟𝘀 𝗮𝗿𝗲 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗰𝗮𝗿𝗿𝘆 𝗼𝘂𝘁 𝘁𝗮𝘀𝗸𝘀 𝗿𝗲𝗳𝗲𝗿𝗿𝗲𝗱 𝘁𝗼 𝗶𝗻 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭𝟬𝟬(𝟮) 𝗼𝗳 #𝗜𝗩𝗗𝗥 #Remember The European Commission has designated five European laboratories as #EuropeanUnion reference laboratories https://lnkd.in/dAXUH58u The EURLs have two main tasks: 📍 advisory ones and 📍 those related to #conformityassessment, particularly of the highest risk, i.e., class D devices. For conformity assessment of class D devices, the EURLs will: ✔️verify the performance of class D devices and compliance with common specifications, ✔️perform batch testing of class D devices. 📌#Notifiedbodies can contract with only one EURL for each device and task under Article 100(2) 📌#Notifiedbodies provide all necessary #documentation and device-related information to the EURL, which can request clarifications on submitted documents. They must also immediately inform the EURL of all new IVD-related information. 📌Manufacturers must supply any equipment or reference materials needed for #performancetesting along with necessary #training. #biotech #biotechnews #invitrodiagnostics #diagnostics #cemark #cemarking
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📢 #Didyouknow Evnia 𝗶𝘀 𝗮 𝘀𝗶𝗹𝘃𝗲𝗿 𝘀𝗽𝗼𝗻𝘀𝗼𝗿 𝗳𝗼𝗿 #𝗛𝗼𝗿𝗶𝘇𝗼𝗻𝟮𝟬𝟮𝟰: 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝘀, 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗮𝗻𝗱 𝗜𝗩𝗗𝘀! Register here: https://horizon-2024.com/ 🌍 #Copenhagen, #Denmark 📅 20-21 November 2024 The conference, chaired by RQM 's Amie Smirthwaite, PhD, FRAPS will examine the interplay between regulatory science, demonstration of device safety and performance, and development of an effective pre-and #postmarket #clinicalevidence strategy. It will also address critical operational issues including #datamanagement, #statistics, cost-effective study design, outsourcing, #reimbursement planning, and more! Stay tuned for more updates! #medtechnews #biotechnews #medtech #biotech #invitrodiagnostics #notifiedbodies #postmarketsurveillance #clinicalinvestigations #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #realworlddata #realworldevidence #cemark #cemarking #EVNIA_AR #Evnia_UKPR #PMCF #regulatoryaffairs Bioevents - Sharing Biomed Knowledge
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𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗯𝘆 𝗘𝘃𝗻𝗶𝗮 : 𝘁𝗵𝗲 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗼𝗳 𝗼𝗳 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻. #Didyouknow Evnia can help you compile the #technicaldocumentation for your portfolio and conduct a gap assessment to identify gaps and/or areas of improvement. If you are in the middle of a #MDR / #IVDR or #QMSR transition looking for cost-effective and agile solutions for the development of Technical Documentation through a streamlined process, reach out for an introductory discussion! Let our team of experts accommodate your quality and regulatory journey! Efstathios Vassiliadis #medtechnews #medicaldevices #biotech #biotechnews #invitrodiagnostics #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs #CEmark #CEmarking #startups #startupbusiness #startupcommunity #startupfunding #startupecosystem #startupstories #qualitymanagement #qualityassurance #audits #fdacompliance https://lnkd.in/gRPjAEGs
Evnia Services - Technical Documentation
https://heyzine.com
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The European Medicines Agency has finalised their reflection paper on the use of #artificialintelligence in the medicinal product lifecycle . The risk-related terminology has been updated by replacing the term “high risk” with “high regulatory impact” and “high patient risk” to highlight that most regulatory requirements are based on the regulations for #medicines. The requirements on #dataavailability used for #drugmodelling, use of third-party AI systems, and the need for prospective testing of #machinelearning models are also discussed. The conclusion of the paper remains unchanged and highlights the importance of keeping a balance between the improvement of the medicinal product's lifecycle, #dataintegrity for regulatory decision-making, and the #patientsafety, which must not be compromised by the introduction of #artificialintelligenceinhealthcare. #pharma #pharmanews #regulatoryaffairs