Alceon helps medical device manufactures to compliant with current regulatory requirements of different regulatory authorities. We are expert in medical device regulatory affairs, QMS, Clinical investigation and other requirements. Alceon founded in year 2019 and, within three year we have completed more than 50 projects in various type of medical devices as well as in vitro diagnostic devices and gain excellent reputation in market. Moreover, Alceon is certified by globally reputed certification body BSI for quality management system in the scope of providing regulatory consultancy services to medical device and IVDs manufacturer. We provides end to end support in regulatory consultancy in below listed area. 1) Indian MDR Test License Manufacturing license Import license Post approval 2) EU MDR Preparation of technical file Review of technical documents and gap analysis Risk Management of devices Post market surveillance Clinical Evaluation 3) USFDA Preparation technical file Review of technical documents and gap analysis Validation of technical file Primary correspondent 4) Health Canada 5)TGA Some other services like 1) ISO 13485 QMS Preparation Implementation Maintenance 2) Trainings on different topics related to medical device regulatory as well as QMS
External link for Alceon Medtech Consulting
Vadodara, Gujarat 390007, IN
Keep your operations running smoothly with our expert Annual Maintenance Services! 🚀 Our team ensures that your systems are always up to date, effective, and compliant. Contact us for unmatched reliability, quality and peace of mind. #MaintenanceExcellence #AlceonMedtech #ReliableService
Selecting the right predicate device is a crucial step in the FDA 510(k) submission process. The predicate device serves as the basis for demonstrating that your medical device is substantially equivalent to one already on the market. Choosing the appropriate predicate can streamline approval, minimize delays, and ensure compliance. In this blog, we'll explore the best practices to help you navigate the selection process effectively and enhance the likelihood of a successful FDA submission. https://lnkd.in/dDgucZjb #FDA 510K #RegulatoryConsulting #PredicateSelection
🌟 Join Alceon Medtech Consulting! 🌟 Are you looking to work in a supportive and collaborative environment where innovation thrives? At Alceon Medtech Consulting, we're expanding our team and seeking passionate professionals who are eager to make a difference in the medical technology industry. Join us and be part of a company that values growth, teamwork, and excellence. Explore our open positions and start your journey with us today! #Hiring #MedTech #SupportiveWorkplace #CareerGrowth #JoinUs
Navigating the complexities of electro medical devices can be challenging, but the IEC 60601 standard provides a clear framework for ensuring compliance and protecting patient well-being. In this post, we’ll introduce you to the IEC 60601, explaining to you some key concepts and definitions. https://lnkd.in/dnvstWDw #MedicalDevices #IEC60601 #RegulatoryCompliance #HealthcareSafety.
The ASEAN is a regional grouping of ten nations set up in 1967 to accelerate economic growth, social progress, and cultural development and promote regional peace and stability. The ASEAN Medical Devices Directive was established to promote regional integration of trade practices and set up the ASEAN Medical Device Committee to oversee its implementation. Learn about the features of this ASEAN Medical Device Directive in our latest blog this week. https://lnkd.in/dKB65-ZA If you have questions or need help registering your devices, please contact us at contact@alceonconsulting.com. #ProductRegistration #ASEANMedicalDeviceRegulation #TechnicalFiles
🌟 Wishing you a joyful and prosperous Diwali! 🌟 May this festival of lights bring happiness, success, and new beginnings. Warm wishes from all of us at Alceon Medtech Consulting. Happy Diwali! ✨ #HappyDiwali #FestivalOfLights #TeamAlceon
Creating a comprehensive Design History File (DHF) is critical in product development, particularly in regulated industries like medical devices. A well-organized DHF helps document the entire design process and ensures compliance with regulatory standards, enhances team communication and serves as a valuable reference for future updates. By creating a thorough and accessible DHF, you set the foundation for a smoother product lifecycle and easier regulatory submissions. Contact us for help with your design planning and to create your entire design file. https://lnkd.in/gZxuvBK8 #ProductDevelopment #DHF #DesignProcess #QualityAssurance #RegulatoryCompliance
Looking for someone who can conduct biological and toxicological risk assessments which are state-of-art and still don’t cost you a bomb? Contact us today for help. Our competent team that includes biotechnologists and American Board Certified and EU Registered Toxicologist can assist you through the process. contact@alceonconsulting.com #ToxicologicalRiskAssessment #BiocompatibilityEvaluation #BiologicalRisk Assessment #BiologicalEvaluationPlan #BiologicalEvaluationReport #ISO10993
We’re back with more insights on electronic IFU requirements, in-line with #EUMDR compliance. In our last blog, we simplified the requirements of (EU) 2021/2226 enlisting essential requirements for a complete transition to e-IFUs. This blog talks about the essentials of e-IFU requirements for overall #EUMDR compliance. Check out the latest blog for a practical guide! https://lnkd.in/dx4uDRJM #AlceonMedtechConsulting #eIFU #EUMDRCompliance #MedicalDevices #Learning&Sharing
Reflecting on a week filled with insightful discussions, new ideas, and moments of laughter. It's incredible how much we can achieve when we come together, share knowledge, and support one another. As we head into the weekend, we are grateful for the opportunity to grow and connect with such inspiring colleagues and friends. We are ready to bring this energy into next week! How did your week wrap up? Share your highlights below! 👇 #WeeklyWrapUp #LearningAndGrowth #Teamwork