Rianne Tooten

⏱ 𝑳𝒆𝒕 𝒕𝒉𝒆 𝒄𝒐𝒖𝒏𝒕𝒅𝒐𝒘𝒏 𝒃𝒆𝒈𝒊𝒏 ✨ Just a little while and we will find ourselves in a new year with new opportunities en developments. I look forward to share my knowledge and 𝘀𝘁𝗮𝘁𝗲-𝗼𝗳-𝘁𝗵𝗲-𝗮𝗿𝘁 training next year. Take a look at my offer here 👉 https://buff.ly/3R6iZHK See you in ✨ 2024 ✨ #training #elearning #ISO14155 #euMDR #clinicalinvestigation #clinicalresearch #happynewyear #riannetooten

𝗥𝗶𝗮𝗻𝗻𝗲 𝗧𝗼𝗼𝘁𝗲𝗻 𝘄𝗶𝘀𝗵𝗲𝘀 𝘆𝗼𝘂 𝗮 𝗹𝗼𝘃𝗲𝗹𝘆 𝗲𝗻𝗱 𝗼𝗳 𝘁𝗵𝗲 𝘆𝗲𝗮𝗿 𝗮𝗻𝗱 𝗮 𝗴𝗿𝗲𝗮𝘁 𝘀𝘁𝗮𝗿𝘁 𝗶𝗻𝘁𝗼 𝟮𝟬𝟮𝟰! 🌲💫 Our office will be closed until the 8th of January 2024 and in the first months of the new year we will be working on some new interesting content for you. So stay tuned! 2024 will be a year in which we will share more lessons learned on medical device clinical investigation challenges. #clinicalinvestigation #ISO14155 #eumdr #training #freelance #clinicalreseach #CRA #CPM #consultancy #riannetooten #ISO20916

🌟 𝗟𝗮𝘀𝘁 𝗖𝗵𝗮𝗻𝗰𝗲 𝗔𝗹𝗲𝗿𝘁! 🌟 Don't miss out on this incredible opportunity! 🚀 𝑻𝒐𝒅𝒂𝒚 𝒊𝒔 𝒚𝒐𝒖𝒓 𝒍𝒂𝒔𝒕 𝒅𝒂𝒚! Join the ISO14155 E-learning course and unlock your potential with a special 20% discount, by using the discount code: “BLACKFRIDAYDEALS”! 🎓💡 🥼 Perfect for investigators or study nurses who have not scored their accreditation points for this year. 👉🏼 Sign up now: https://lnkd.in/d_jsTz_w #iso14155 #clinicalinvestigation #medicaldevices #elearning #training #riannetooten #accreditation

𝗜𝗻 𝘁𝗵𝗶𝘀 𝗻𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿 𝗲𝗱𝗶𝘁𝗶𝗼𝗻: 🌟Discount on the ISO14155 e-learning 🌟NEW! ISO20916:2019 training 🌟Upcoming and past events 🌟Holiday office closure Enjoy! All the best, Rianne Tooten 

𝗪𝗵𝗲𝗻 𝗶𝘀 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗲𝗱 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲?🔍 During the qualification it is investigated if the software falls within the scope of the MDR/IVDR and therefore has to follow the requirements within the MDR/IVDR. The MDCG 2019-11 defines MDSW as “𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝘁𝗵𝗮𝘁 𝗶𝘀 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗯𝗲 𝘂𝘀𝗲𝗱, 𝗮𝗹𝗼𝗻𝗲 𝗼𝗿 𝗶𝗻 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻, 𝗳𝗼𝗿 𝗮 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 𝗮𝘀 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗲𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗱𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 𝗼𝗳 𝗮 “𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲” 𝗶𝗻 𝘁𝗵𝗲 𝗠𝗗𝗥 𝗼𝗿 𝗜𝗩𝗗𝗥, 𝗿𝗲𝗴𝗮𝗿𝗱𝗹𝗲𝘀𝘀 𝗼𝗳 𝘄𝗵𝗲𝘁𝗵𝗲𝗿 𝘁𝗵𝗲 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗶𝘀 𝗶𝗻𝗱𝗲𝗽𝗲𝗻𝗱𝗲𝗻𝘁 𝗼𝗿 𝗱𝗿𝗶𝘃𝗶𝗻𝗴 𝗼𝗿 𝗶𝗻𝗳𝗹𝘂𝗲𝗻𝗰𝗶𝗻𝗴 𝘁𝗵𝗲 𝘂𝘀𝗲 𝗼𝗳 𝗮 𝗱𝗲𝘃𝗶𝗰𝗲”. 👉🏻𝙏𝙤 𝙠𝙚𝙚𝙥 𝙞𝙩 𝙨𝙞𝙢𝙥𝙡𝙚: For software to qualify as MDSW, a comparison of the intended purpose of the software and the definition of a Medical Device is made. If it matches, then the software is called MDSW. would you like to learn more about MDSW? 𝗝𝗼𝗶𝗻 𝗺𝗲 𝗶𝗻 𝘁𝗵𝗲 𝘂𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲: https://lnkd.in/eTQp-jED #eumdr #mdsw #training #riannetooten #medicaldevices #euIVDR

✨ 𝗕𝗹𝗮𝗰𝗸 𝗙𝗿𝗶𝗱𝗮𝘆 𝗱𝗲𝗮𝗹 𝗶𝘀 𝘀𝘁𝗶𝗹𝗹 𝘂𝗽! ✨ Get yourself certified with this great 20% discount on the 𝗜𝗦𝗢𝟭𝟰𝟭𝟱𝟱 𝗘-𝗟𝗘𝗔𝗥𝗡𝗜𝗡𝗚 GET CERTIFIED NOW:  If you would like to be MDR compliant! Are you an investigator or study nurse and you haven't scored your accreditation points for this year yet? Get yourself certified on the ISO14155 standard and gain 4 accreditation points! This training is especially important for any party involved in clinical investigations with medical devices, who are looking for answers on how to practically implement this Good Clinical Practice into their daily practice. You can get a 𝟮𝟬% 𝗕𝗹𝗮𝗰𝗸 𝗙𝗿𝗶𝗱𝗮𝘆 𝗱𝗶𝘀𝗰𝗼𝘂𝗻𝘁 by using the discount code: BLACKFRIDAYDEALS Valid from November 24th to December 22th. 𝗧𝗵𝗲𝗿𝗲 𝗶𝘀 𝗰𝘂𝗿𝗿𝗲𝗻𝘁𝗹𝘆 𝗮 𝗴𝗿𝗲𝗮𝘁 𝗻𝗲𝗲𝗱 𝗳𝗼𝗿 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗽𝗲𝗿𝘀𝗼𝗻𝗻𝗲𝗹𝘀 𝘄𝗶𝘁𝗵 𝗳𝗼𝗰𝘂𝘀 𝗼𝗻 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀. 𝗠𝗮𝗸𝗲 𝘀𝘂𝗿𝗲 𝘆𝗼𝘂 𝗮𝗿𝗲 𝘁𝗿𝗮𝗶𝗻𝗲𝗱 𝗼𝗻 𝘁𝗵𝗲 𝗹𝗮𝘁𝗲𝘀𝘁 𝗜𝗦𝗢𝟭𝟰𝟭𝟱𝟱. 👉🏼 Sign up now: https://lnkd.in/dqm-_tCZ #iso14155 #clinicalinvestigation #medicaldevices #elearning #training #blackfriday #riannetooten #accreditation

𝗝𝗼𝗶𝗻 𝗺𝗲 𝗶𝗻 𝘁𝗵𝗲 𝘂𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 🩻 Are you dealing with software and wondering if your software might be fulfilling the Medical Device Software (MDSW) qualifications? Then please join this webinar in which you will learn all about #MDSW Wether you are a medical device manufacturer, pharmaceutical or software company or all in between. This webinar will give you the insights that you need. #medicaldevices #euMDR #riannetooten #software #clinicalinvestigation #clinicalresearch #training

✨ 𝗕𝗹𝗮𝗰𝗸 𝗙𝗿𝗶𝗱𝗮𝘆 𝗦𝗮𝗹𝗲 𝗜𝗦𝗢𝟭𝟰𝟭𝟱𝟱 𝗘-𝗟𝗘𝗔𝗥𝗡𝗜𝗡𝗚! ✨ GET CERTIFIED NOW: If you would like to be MDR compliant! Are you an investigator or study nurse and you haven't scored your accreditation points for this year yet? Get yourself certified on the ISO14155 standard and gain 4 accreditation points! This training is especially important for any party involved in clinical investigations with medical devices, who are looking for answers on how to practically implement this Clinical Practice into their daily practice. You can get a 𝟮𝟬% 𝗕𝗹𝗮𝗰𝗸 𝗙𝗿𝗶𝗱𝗮𝘆 𝗱𝗶𝘀𝗰𝗼𝘂𝗻𝘁 by using the discount code: “BLACKFRIDAYDEALS” Valid from November 24th to December 22th. 👉🏼 Sign up now: https://buff.ly/3lRTwDn #iso14155 #clinicalinvestigation #medicaldevices #elearning #training #blackfriday #riannetooten #accreditation

𝗜𝗦𝗢 𝟭𝟴𝟵𝟲𝟵 - 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗶𝘀 𝘀𝗲𝘁 𝘁𝗼 𝗯𝗲𝗰𝗼𝗺𝗲 𝗮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗴𝗮𝗺𝗲-𝗰𝗵𝗮𝗻𝗴𝗲𝗿 ISO 18969, currently at stage 20.00 in its development, is set to become a significant game-changer in the world of medical devices. It's expected to reach finalization by 2025 and is aimed at establishing the crucial guidelines for the clinical evaluation of medical devices. 𝗛𝗲𝗿𝗲'𝘀 𝘄𝗵𝘆 𝘆𝗼𝘂 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗮𝗿𝗲 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗶𝘀 𝗶𝗺𝗽𝗲𝗻𝗱𝗶𝗻𝗴 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱: 📈 Safety & Performance: ISO 18969 serves as a comprehensive guide, ensuring that medical devices meet the highest standards of safety and effectiveness. If you've been grappling with the complexities of the Medical Device Regulation (MDR), this standard could be your new go-to resource for clarity and compliance. 🌐 One Strategy for All Markets: Imagine a world where there's a single, universally accepted clinical strategy for medical devices. ISO 18969 strives to make this a reality. This means that medical device manufacturers won't have to tailor their clinical evaluation processes to fit various regional requirements, making it easier to bring their products to a global market. 🔎 A Real Asset: ISO 18969 is shaping up to be a valuable tool for meeting MDR requirements. By following the guidelines outlined in this standard, medical device companies can not only enhance their products' safety and performance but also streamline their regulatory compliance efforts, saving time and resources in the process. 𝗪𝗵𝗮𝘁'𝘀 𝗡𝗲𝘅𝘁? Keep a keen eye on ISO 18969 and its progression. As it moves closer to becoming an official standard, it has the potential to revolutionize how we approach clinical evaluation in the medical device industry. Whether you're a manufacturer, healthcare professional, or someone interested in the safety and performance of medical devices, ISO 18969 is a development worth monitoring closely. #clinicalevaluation #medicaldevices #euMDR #riannetooten #clinicaldata #ISO18969

📢 𝗔𝗻𝗼𝘁𝗵𝗲𝗿 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 (𝗠𝗗𝗦𝗪) 🏥🔬 In the ever-evolving world of medical devices, the pivotal role of software can’t be overstated. But, it’s the synergy between software and hardware that’s now in the spotlight. 🤝🌐 🔍 Dive into the latest MDCG guidance document that explores the critical regulatory considerations when hardware, especially integrated sensors, meets Medical Device Software. 📲💻 Discover when these components are deemed medical devices or accessories, and when they’re not. 🤷♂️🏢 Get ready to unravel the intricacies of this dynamic field and stay ahead of the game. 🚀📚 #euMDR #medicaldevices #guidance #riannetooten #mdcg #MDSW