iFyber’s Post

How is your Medical Device regulatory intelligence and compliance strategy stacking up? Give us your feedback and watch for results at MedTechIntelligence.com Take the survey: https://lnkd.in/e49Qt3VG

Compliance to the MDR is the only way to keep you medical device on the EU market, read here our dedicated blog.

Whether you’re new to the medical device market or a seasoned medtech releasing a new type of product, knowing what you need to include, and how to get started with your technical file for the MDR isn’t straightforward. Here’s our roadmap for compliance.

🚀 Exciting News Alert! 🚀   We are thrilled to announce the launch of our newest service dedicated to Medical Device Regulatory Intelligence! 🎉   Navigating the complex landscape of medical device regulations just got easier with our comprehensive regulatory intelligence service. Stay ahead of the curve with real-time updates, insights, and expert analysis tailored to your specific needs.   Whether you're a start-up breaking into the industry or an established player looking to enhance your regulatory strategy, our service is your go-to resource for staying informed and achieving compliance. Find out more on how we can help : https://lnkd.in/eZv7828w #MedicalDevices #RegulatoryIntelligence #Launch #StayInformed

Finally, a way to be confident in your medical device regulatory journey. RegNav helps to save time, effort, and complications from the start with our unique online tool developed by our principle medical device experts. Already identified what standards you think are applicable? Use RegNav Verify for a free assessment of your compliance plan to assist with determining if you have found all applicable standards. Clear your path to compliance with RegNav. Try It Here https://ow.ly/T7ZJ50SNbx9 #RegulatoryCompliance #MedicalDevices #MedTech #RegulatoryAffairs #ComplianceSimplified #DeviceRegulation #RegulatoryGuidance #SimplifyCompliance #ElementRegNav #RegNav

With Element RegNav you begin your journey by entering the following… My medical device is intended for… It achieves its function through the following scientific and principles of operation… It has these technological characteristics… Once input ‘hey presto’ we navigate you to your journey towards safe, effective and regulatory compliant technologies and on the way you get… A detailed overview of the essential principles of safety and performance (or other more specific regional safety and performance requirements) A detailed overview of the requirements from standards, regulations, guidelines and previous submissions via human supervised data science and AI. A breakdown of the verification, validation activities that rely upon well defined and often standardised test methods Links to conformity assessment bodies and testing laboratories so you can begin your medical device product development and introduction. Why? 1. Increase accuracy of requirements to give more certainty around safety and performance 2. Predict costs and implications within your product development to improve investor confidence and timescales 3. Ensure that you have a predictable pathway to regulatory market authorisation reducing unanticipated delays, regulatory questions and ultimately costs 4. Give assurance of development risk defence knowing that you are achieving a high level of protection in accordance with the generally acknowledged state of the art. Making tomorrow safer than today.

Attention…. If you’re planning a medical device regulatory submission or simply doing an internal audit of your strategy for regulatory compliance take a look at our new ‘verify’ service. Have the chance to input your medical device product intended purpose and technological characteristics to see whether or not the essential principles and standards you intend to apply are in line with the generally acknowledged state of the art. Ideal for NPI project managers, compliance and regulatory professionals and auditors to ensure that you are focussed on the right requirements. You never know ‘verify’ may help you avoid or anticipate a Notified body or FDA question. Element RegNav try it out!!! #medicaldevicedesign #medicaldeviceinnovation #FDA #EUMDR #Notifiedbody #medicaldeviceauditing #Medicaldevicemarketaccess #ISO13485 #ISO14971 #ISO10993 #IEC60601 #IEc80601

🔍 Discover the Latest in Medical Device Regulation! 🚀 Dive into the newest insights on regulatory strategies with Medical Device Network. This post covers key compliance challenges, best practices, and the evolving landscape that's shaping the industry. 📈💡 This is a must-read for professionals navigating the complex world of medical device regulations. Stay ahead of the curve and ensure you're up-to-date with the latest standards and strategies. 🔗 Read the full article here! https://tiny.pl/m85d0y57 #MedicalDevices #RegulatoryAffairs #Compliance #HealthcareInnovation #IndustryInsights

If you are a start-up medical device company facing time constraints and struggling with navigating complex regulatory requirements, RegNav offers a simplified process to bring your lifesaving or life-enhancing product to market. Explore it yourself and schedule a Demo today! 📅https://ow.ly/xxzZ50SWNJA #MedicalDeviceRegulations #InnovationForGood #RegulatoryCompliance #MedicalDeviceIndustry #RegulatoryAffairs #MedDevice #FDACompliance #ElementRegNav #RegNav

𝗔𝗰𝗰𝗼𝗿𝗱𝗶𝗻𝗴 𝘁𝗼 𝗺𝗼𝘀𝘁 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝘁𝗵𝗲 𝗻𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗯𝗼𝗱𝘆 𝗰𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗶𝘀 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗶𝗻𝗴 𝗽𝗮𝗿𝘁 𝗼𝗳 𝘁𝗵𝗲 #𝗖𝗘𝗺𝗮𝗿𝗸𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝘀𝘀.    Our #EUMDR expert Pontus Gedda outlined the conformity assessment procedure in this flow chart to help you navigate.    🎓 This topic is part of our online course Introduction to the Medical Device Regulation (EU) 2017/745 https://bit.ly/3Y4MMqt which covers an orientation of the MDR and related guidance documents such as the MDCG and how to apply for a conformity assessment. ▶ Watch Pontus’ explanation of conformity assessment procedures for medical device manufacturers in this short video: https://lnkd.in/dDCXwXF9    #MedicalDevices  #QualityAssurance