Irish Medtech Springboard’s Post

Introducing the EUSTAR Executive Regulatory Management Program: Fundamentals of MDR: Free Nine-Day Course 👇👇 Register now: https://lnkd.in/e8j3wGKv I am pleased to announce that the Johner Institut GmbH, in collaboration with MedTech Leading Voice,  has launched the EUSTAR Executive Regulatory Management Program. This FREE nine-part online course on the fundamentals of EU medical device regulation offers a comprehensive understanding essential for all MedTech professionals. Course Highlights: ✅ Daily 15-Minute Sessions: Perfect for busy professionals, each session delivers impactful insights in just 15 minutes. ✅ Expert Instruction: Learn from Christian Johner, a leading expert in regulatory affairs and digital transformation. ✅ Hands-on Learning: Engage with easy-to-follow lessons and self assessment quizzes. ✅ Certificate of Completion: Earn a certificate upon completing the course, showcasing your new skills. Topics Covered: 1. Introduction to MDR 2. Essential Requirements 3. Device Classification 4. Conformity Assessment 5. Unique Device Identification 6. Clinical Evaluation & PMCF 7. Post-Market Surveillance 8. Roles & Responsibilities 9. Quality Management System Why Enroll? - Build your regulatory executive management skills. - Tailored for senior professionals aiming to make significant organizational impacts. - Preview over 300 online courses from the Johner Institute’s Medical Device University. Register Now for this Special Offer! https://lnkd.in/e8j3wGKv #eumdr #QMS #regulatoryaffairs #careerdevelopment

Informative and engaging courses! I highly recommend to those new to industry.

🎉 Excited to share that I have successfully completed the "Medical Device Regulation 2017/745 EU Regulatory Affairs" course on Udemy! 📜  This comprehensive training provided me with essential insights into the EU Medical Device Regulations (MDR), focusing on compliance, regulatory pathways, and the intricate processes of medical device approvals in Europe. I am deeply grateful to the instructor, Martin Conneely, for delivering such a well-structured and informative course. This knowledge will greatly assist me in understanding and navigating the regulatory aspects of medical devices, paving the way for innovation and compliance in the healthcare sector. Looking forward to applying these learnings to my career in biomedical engineering! 💡 #MedicalDevices #RegulatoryAffairs #MDR #HealthcareInnovation #ContinuousLearning

Following several recent articles reflecting on the decline in the medical representatives (MR) population of the Japanese pharmaceutical industry, the impact of the Labor Law Reform (especially on doctors' working hours reduction), the interview of Y. Chikazawa of the MR Certification Center by MIX Online comes at the right time. The MR Certification Center is set to reform its certification system from 2026, focusing on "lifelong learning for MRs." Executive Director Yohei Chikazawa emphasizes the importance of independent professionals contributing to the proper use of medicines. The new system will be a two-tiered education and training system, combining individual MRs' learning with corporate education. The focus is on lifelong learning, with individuals taking responsibility for honing the basic knowledge necessary for the proper use of medicines. The environment has changed significantly since the establishment of the MR certification system in 1997, with drug therapy becoming more advanced, specialized, and individualized. The rapid development of ICT and the COVID-19 pandemic have further accelerated this change. As a result, many companies are restructuring, from the peak at around 65,000 in 2013 to less than 50,000 nowadays. Despite facing challenges, MRs' role of providing information on pharmaceuticals to benefit patients remains unchanged. The new "MR Basic Exam" will abolish eligibility requirements and be available to anyone, including those working in the pharmaceutical industry. The exam will include topics such as "Drug Information," "Diseases and Treatment," and "Pharmaceutical Industry and Ethics, Laws, and Systems." The Certification Center is also considering ways to guarantee qualifications for people in positions other than MR and use the system uniquely through promotion exams. The future image of MRs after the system revision is expected to be a partner trusted by medical professionals through the provision, collection, and transmission of information on the proper use of medicines based on patient orientation. #pharmasalesexcellence #salesrepresentative #pharmasellingskills #pharmajapan #medicalaffairs

You know you are in the right field when you spend 4 days training a research naïve site on GCP, trial management, and good quality management systems, and they still think the most valuable part of the training was YOU🥰 I finally found a field where my two passions converge! Medical innovation & education! #grateful #clinicalresearch #ppd #thermofisherscientific #training #goodclinicalpractice #clinicaltrials #learninganddevelopment #corporatetraining

🚀 Regulatory Education for Industry: Clinical Investigator Training Course (November 2019) Discover critical insights into advanced clinical trial design, regulatory requirements, and emerging technologies directly from FDA experts. This training course is a must-have for professionals in clinical research and regulatory affairs. 📄 The comprehensive PDF includes accessible links to video recordings and slides, providing a rich resource for advancing your expertise in clinical investigations. 🔗 Download the Comprehensive PDF Summary to boost your skills and knowledge! 🎓✨ Note: In the PDF viewer, look for the download icon (usually a down arrow or “Download” button). Click it to save the PDF to your device. Confirm Download: Open the file to ensure it downloaded correctly. If you face any issues, feel free to inbox me or share your email, and I can send the PDF copy directly to you. #ClinicalResearch #RegulatoryAffairs #FDA #ClinicalTrials #regulatoryexcellence #ProfessionalDevelopment #LifelongLearning #MedicalInnovation #sfda #gcc #research #knowledgesharing #learning

We're delighted to have Malene Nybo Othendal Nielsen, Biocompatibility Specialist, QCO, Quality Services at Convatec joining Marina Daineko, Biocompatibility Consultant at Intrinsic Medical Group, LLC, bringing their knowledge and expertise to this year's Medical Device School! This structured training will give you a bigger picture view of the whole medical device landscape and help you understand how to best maximise your role within in! Malene and Marina will be providing training on an "Introduction to Biocompatibility", covering the essentials of biocompatibility assessment. Explore the medical device lifecycle and determine when biological evaluations should be performed. Explore examples and discuss common mistakes in each phase. And, get to grips with updates to the current draft of ISO 10993-1 in Biological Evaluation within the Medical Device Lifecycle section. What is Biocompatibility? - Definition - What, why, and how should it be assessed? Biological Evaluation within the Medical Device Lifecycle - Prototype - Design Verification - Production and Post-Production Activities - Changes to Medical Devices - Emerging Post-Market Information Real-Life Non-Conformities Open Discussion: - Key considerations for updating Biological Evaluation Reports to align with upcoming ISO 10993-1 changes. Ready to elevate your knowledge of the wider medical device regulatory landscape and ensure submissions best practice? Register today: https://lnkd.in/e4JzwM2S #MedicalDeviceSchool #MedTech #MedicalDevices #RegulatoryAffairs #Biocompatibility #ISO10993

New Zealand businesses looking to enhance their skills in medical regulations may now be eligible for funding through the 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗖𝗮𝗽𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗙𝘂𝗻𝗱 for our upcoming 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 and 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 (𝗤𝗠𝗦) courses. This funding could help cover the costs of these courses, making them more accessible for businesses aiming to build expertise in the MedTech industry. Starting this September, Johner Institute New Zealand offers two key online courses for professionals in the MedTech space: - 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 (beginning 18 September 2024, NZD 1,800/month): This three-month course is ideal for those looking to build a strategic regulatory plan for faster market entry. Learn how to navigate complex regulations and align your strategy with industry best practices. https://lnkd.in/gkTcNjix - 𝗤𝗠𝗦 𝗕𝗮𝘀𝗶𝗰𝘀 (starting 19 September 2024, NZD 1,600/month): Over six months, this course dives deep into ISO 13485 and FDA 21 CFR 820 standards, teaching you how to establish and maintain a compliant QMS. Perfect for organisations that need a solid foundation in quality management. https://lnkd.in/etZEm8Nt 𝗙𝘂𝗻𝗱𝗶𝗻𝗴 𝗢𝗽𝘁𝗶𝗼𝗻𝘀: The great news for New Zealand businesses is that services registered under the 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗖𝗮𝗽𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗙𝘂𝗻𝗱 may be eligible for funding to help cover these course fees. Small businesses that qualify could access funding support through the Regional Business Partner Network (RBP) for these essential training workshops, coaching, and more. For more information on the fund and to check eligibility, visit the Regional Business Partner website https://lnkd.in/g4CbW2t. This is a great opportunity to develop critical skills in regulatory and quality management, while potentially reducing costs through available funding. To learn more and sign up for these courses, visit the Johner Institute New Zealand website https://lnkd.in/eW_kJPJ7 #MedTech #QualityManagement #RegulatoryStrategy #QMS #NZBusiness #RBP

❗ Attention please! ❗   I'm super excited to be a course leader for the Medical Device School live online training course organized by Informa Connect, 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 Block your calendar on the 6th Nov from 3:45pm to 5:45pm CET for Biocompatibility!   Marina Daineko and I will dive into the concepts of Biocompatibility where we will explore the medical device lifecycle and discuss how and when biological evaluations should be performed. We will bring examples, facilitate open discussions and we hope you are ready to join us!   View the full agenda to learn more: https://lnkd.in/ew-x-4b2   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/e_SyfcW2   I hope to see many of you there with me!   #MedicalDevice #MedTech #EUMDR #UKCA #MedicalDeviceRegulations #RegulatoryAffairs

What defines sufficient quality and evidence in the clinical development of medical devices? This online training provides a thorough exploration of regulatory requirements, equipping you with the knowledge to design an effective clinical development plan. Delve into regulatory pathways, gain detailed insights into clinical evaluation and investigation processes, and understand the critical requirements for post-market surveillance. Whether you’re looking to strengthen your foundational knowledge or refine your strategies, this training offers the tools and expertise you need. Learn more about the course and how to register by visiting our website. #pharma #medicaldevices #clinicalinvestigation #clinicalevaluation #onlinetraning