🎉Excited to share that I have successfully completed the "Medical Device Regulation 2017/745 EU Regulatory Affairs" certification from Udemy! 🚀 This program has provided me with valuable insights into the EU MDR (2017/745), enhancing my understanding of regulatory frameworks, compliance, and the evolving medical device industry. #EUCompliance #MedicalDevices #RegulatoryAffairs #EUMDR #CareerGrowth #LifelongLearning #ProfessionalDevelopment #MedicalDeviceIndustry #HealthTech #DigitalHealth #MedicalSoftware #HealthcareIT #HealthInnovation #MedTech #ClinicalSoftware #HealthData #RegulatoryCompliance #HealthcareTechnology #SoftwareDevelopment #EHealth #SaMD #AIinHealthcare #HealthInformatics #DataSecurity #HealthcareRegulations #Telemedicine #HealthAppDevelopment

Yes! Our RAMS e-learning training library is live now! Let RAMS enhance your regulatory knowledge of global medical device regulations. Sign up for a complimentary account today at: RAMS.EmergobyUL.com #weareulsolutions #EmergobyUL #regulatory #medicaldevice #IVD #elearning #training

Exciting news for medical device regulatory affairs professionals, Our RAMS e-learning training library is live now! This e-learning training provides convenient, expert-designed digital courses on key topics. Let RAMS enhance your regulatory knowledge of global medical device regulations. Sign up for a complimentary account today at: RAMS.EmergobyUL.com #regulatory #elearning #regulatoryaffairs #medtech #compliance

🔬🩺🆕✅ I am happy to share that I have completed the “Medical Device Regulation 2017/745 EU regulatory affairs” course from Udemy! 🔝🌟 The course provided me with a solid foundation in European Union medical device regulatory affairs, a crucial aspect of ensuring medical devices are safe and effective for patients, understanding the regulations to gain market approval of a medical device in the EU 📝 🎯 Looking forward to contributing to the safety and efficacy of medical devices and applying my knowledge in the life sciences and advanced manufacturing industries 🔬🩺🏭 MUCH MORE TO COME! 🔜 💡 The program's key takeaways: ✔ Economic Operators: European Authorised Representative (EAR), Distributor, Importer, Manufacturer, Person Responsible for Regulatory Compliance (PRRC) ✔ EUDAMED System: UDI, UDI-DI, UDI-PI, Single Registration Number (SRN) ✔ Conformity Assessment ✔ Post Market Surveillance: Report (PMSR), Periodic Safety Update Report (PSUR) #MedicalDevices #EURegulations #MDR #UDI #EUDAMED #QSR #MedTech #RegulatoryAffairs #QualitySystems

I'm excited to be a course leader for the Medical Device School live online training course, taking place on 5-7 November 2024. This comprehensive training will give you access to 14 course trainers, each covering their fields of expertise to give you in-depth knowledge of how the medical device industry interacts to bring products from concept to market. Develop the knowledge-base necessary to ensure global submissions best practice and streamline market access, diving into:  ·       EU MDR ·       Medical device stakeholder relations and collaboration ·       Classification and conformity assessment ·       Biocompatibility ·       Risk management ·       Clinical evaluations, investigations and evidence ·       Quality management system (QMS) implementation ·       Post market surveillance & vigilance ·       UK market access (UKCA) ·       Drug device and borderline products ·       Labelling requirements View the full agenda to learn more: https://lnkd.in/eHHxV8wH Ready to elevate your career, master regulatory pathways and accelerate compliance? Register today and get 10% off with my referral code: MDLEADER10 : https://lnkd.in/ejv4wyHM I hope to see many of you there with me! #MedicalDevice #MedTech #EUMDR #UKCA #MedicalDeviceRegulations #RegulatoryAffairs

Exciting news for medical device regulatory affairs professionals, our RAMS e-learning training library is live now! This e-learning training provides convenient, expert-designed digital courses on key topics. Let RAMS enhance your regulatory knowledge of global medical device regulations. Sign up for a complimentary account today at: RAMS.EmergobyUL.com #regulatory #elearning #regulatoryaffairs #medtech #compliance

Exciting news for medical device regulatory affairs professionals, Our RAMS e-learning training library is live now! This e-learning training provides convenient, expert-designed digital courses on key topics. Let RAMS enhance your regulatory knowledge of global medical device regulations. Sign up for a complimentary account today at: RAMS.EmergobyUL.com #regulatory #elearning #regulatoryaffairs #medtech #compliance

I'm excited to be a course leader for the Medical Device School live online training course, taking place on 5-7 November 2024.   This comprehensive training will give you access to 14 course trainers, each covering their fields of expertise to give you in-depth knowledge of how the medical device industry interacts to bring products from concept to market. Develop the knowledge-base necessary to ensure global submissions best practice and streamline market access, diving into: ·    EU MDR ·    Medical device stakeholder relations and collaboration ·    Classification and conformity assessment ·    Biocompatibility ·    Risk management ·    Clinical evaluations, investigations and evidence ·    Quality management system (QMS) implementation ·    Post market surveillance & vigilance ·    UK market access (UKCA) ·    Drug device and borderline products ·    Labelling requirements   View the full agenda to learn more: https://lnkd.in/dq6KU9wY   Ready to elevate your career, master regulatory pathways and accelerate compliance?   Register today and get 10% off with my referral code: MDLEADER10 : https://lnkd.in/duw69scy   I hope to see many of you there with me! #MedicalDevice #MedTech #EUMDR #UKCA #MedicalDeviceRegulations #RegulatoryAffairs

Pop Quiz: How complete is your CER?    The Clinical Evaluation Report (CER) is a comprehensive analysis of pre-market and post-market clinical data relevant to a medical device. It’s designed to assess the safety and performance of your medical device, and it’s a critical component of your EU MDR application.  Write a good one, and your path to certification becomes a little bit easier. Write a bad one, and your application will be delayed indefinitely. Unfortunately, notified bodies have reported that up to 75% of technical documentation submitted with EU MDR applications is incomplete – including the CER. This is due in part to the limited guidance on the format and content of a CER. Medical devices vary greatly, so a one-size-fits-all approach to writing a CER is not practical. In addition, the regulations are constantly being updated, making it difficult to stay on top of industry best practices. Reliant Life Sciences can help. Our regulatory consultants are experts in writing for medical devices, and they know well the challenges companies face when trying to write technical documentation. We can help you develop clear, concise, and accurate technical documentation, including user manuals, device descriptions, and labeling. We’ll work closely with you to draft a comprehensive, well-structured and fully compliant CER that your notified body will gladly accept. Don’t risk having your CER declined. Protect your submission with a qualified medical writer from  Reliant Life Sciences. https://lnkd.in/eWcQEkCN #qualitymanagement #medicaldevices #compliance #lifescience #biotech #pharma #medtech #regulations #eumdr #cer #vigilance #safetyreporting 

When hard work pays off🔥 I'm thrilled to announce a new #milestone, I've completed a comprehensive RA course and got a new certification "Green Belt EU MDR 2017/745" 🌟🎓 in #Medical_Devices regulations certified by Easy Medical Device 💯 I'd like to thank you Monir El Azzouzi for the great, informative and knowledgeable program to understand the EU MDR Key aspects starting with the commence date of EU MDR, the roles of #economic_operators, how to qualify a medical device, how to classify MD, choose appropriate #conformity_assessment to place product on the market, holistic overview on #Technical documentation #Clinical Evaluation #PMS #Vigilance #UDI #EUDAMED and EU #MDR / #IVDR transition timelines ⏳ Super excited to leverage what I've learned and can apply towards good impact to reach the ultimate objective of ensuring #regulatory compliance and the #innovative medical device market access 📈🚀 serving our Patients which aligns with our #JNJ_CREDO "The key to success is to love what you do and do what you love" ♥