Yallow Life Science
845 followers
- Report this post
New Regulatory Amendments Alert: MDR & IVDR UpdateThe recent amendment to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marks a significant shift in how manufacturers and distributors of medical devices and in vitro diagnostics will manage their supply chains within the EU. Here's what you need to know:1️⃣ Supply Chain Transparency: The amendment introduces an approach, requiring manufacturers to notify relevant parties of any supply disruptions or discontinuations at least six months in advance. This mandate is aimed at mitigating patient harm and requires a comprehensive risk assessment in affected member states.🔧 Ensuring compliance by January 2025 demands foresight and robust planning. Yallow Life Science can assist in refining your distribution agreements and Quality Management Systems (QMS) to meet these new requirements.2️⃣ Eudamed Roll-Out: Gradual implementation of the Eudamed database modules is underway. While the complete roadmap is not yet set, it's crucial to prepare to integrate and utilize this system as it becomes fully operational.3️⃣ IVDR Deadlines Adjusted: Analogous to recent changes in the MDR, the IVDR sees adjusted timelines for filing technical documentation and QMS applications, reflecting a staggered compliance schedule.🔄 Continuous Updates: As the EU Parliament elections and Commission reshuffle conclude, we anticipate more updates and targeted evaluations of MDR and IVDR in 2025. Staying informed and agile is key.🤝 Stay Prepared with Us: Navigating these regulatory waters can be challenging. Connect with us to ensure that your compliance strategies are as effective and seamless as possible.#medicaldevice #medtech #EUMDR #EUIVDR #MDRImage is AI generated.
8
To view or add a comment, sign in
More Relevant Posts
-
Yallow Life Science
845 followers
- Report this post
Friday Lunch with Yallow Fellows! ☀️🌸A heartfelt thank you to all our customers and partners for your support through the first half of 2024. We look forward to reconnecting in August!Kean Beng Ho Torbjoern Oeilo Jacobsen Amrita Kaur Ira Sharma Sankhayan Mikkel Lager Krisztián Mundrut Eirik Smolan Mohammad Albatat
10
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
See AlsoUnderstanding eIFU for Medical Devices: EU Regulations Explained.CE marking for Medical Device Software: a step-by-step guideWhat is a medical device according to the MDR - Medical Device HQ 1Medical Device Classification according to the MDR - Complete Guide- Report this post
🌞 Happy Summer from all of us at Yallow Life Science! 🌞As we step into the warmer months, we wanted to take a moment to express our gratitude to our amazing team, loyal clients, and the supportive community around us. Your hard work, commitment, and trust inspire us every day!Whether you're planning to relax on a sunny beach, explore new places, or enjoy some quiet time at home, we wish you a fantastic summer filled with joy and relaxation!#Summer2023 #Gratitude #TeamAppreciation #StayCool
18
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Yallow Life Science is pleased to announce that we have successfully passed the recertification audit of the Quality management systems according to #ISO13485 last week. The audit was carried out by the certification institute RISE Research Institutes of Sweden. We would like to thank the whole team for the dedicated work, specifically our CCO and QMS guru Kean Beng Ho for his hard work and attention to detail. Our team celebrated the success with a spirited match of Padel!
21
2 Comments
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Yet another collaboration, Yallow Life Science together with Oslo universitetssykehus Inven2. Our CEO Ira Sharma Sankhayan and COO Mohammad Albatat presented on importance of clinical investigation of a medical device. If you want to learn more about #clinicalinvestigation of a #medicaldevice, reach out to Yallow Life Science!Check this out: https://lnkd.in/dd36Whsx #medisinskutstyr #medicaldevices #yallowlifescience #medicaldeviceregulation #regulatoryaffairs
20
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Yallow Life Science with Norway Health Tech held a course on risk management standard. Course was held by Mohammad Albatat Mikkel Lager.Stay up-to-date with the latest risk management standards in the medical device industry. Our training course on ISO 14971 covers all the normative references, general requirements for risk management systems, risk analysis, risk evaluation, and risk control.
9
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Ira Sharma Sankhayan Mohammad Albatat at EpiGuard for an Internal Audit last week. Customer Feedback: "Thank you for a fantastic internal audit with good discussions and feedback from Yallow. We appreciate it."At Yallow Life Science, we believe in the power of thorough and insightful audits to ensure robust and compliant business practices. We are proud to partner with organisations like EpiGuard to help them achieve their operational goals with confidence.Here’s to many more successful collaborations and a future of sustained growth and integrity for all our clients! Reach out to us. #AuditSuccess #Collaboration #BusinessExcellence #InternalAudit #TeamAchievement #Compliance #TrustAndTransparency
33
2 Comments
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Over the weekend Yallow Life Science visited Vinngroup for some insightful discussions, future plans and amazing rooftop meetings!Did you know that Yallow Life Science is a part of Vinngroup – a platform for starting up new, innovative service providers. With 300+ employees in 16 companies, with different core competencies, we have a solid foundation for supporting (almost) any type of organisation. Lars Idmyr Mohammad Albatat Ira Sharma Sankhayan Jonas Länje Qing AB
55
1 Comment
Like CommentTo view or add a comment, sign in
-
Yallow Life Science
845 followers
- Report this post
Yallow Life Scienceis happy to announce the successful completion of an another course for Glamox: Introduction to Medical Device Regulation held by Amrita Kaur, our QARA Specialist. The course was tailored specifically to Class I medical device manufacturers using real life examples from the company.We thank youTommy Christer Larsen and his teamatGlamoxfor his team's active participation, insightful feedback, and the trust placed inYallow Life Science yet again.For organisations seeking to elevate their understanding of quality management systems and/or regulations in the medical device sector,Yallow Life Scienceis your go-to partner. Reach out to us today!#YallowLifeScience#QualityManagement#ISOStandards#MedicalDevices#RegulatoryAffairs#ProfessionalTraining#ContinualLearning#QualityAssurance
17
Like CommentTo view or add a comment, sign in
845 followers
View Profile
FollowMore from this author
- For lite fokus på hjernen Yallow Life Science 1y
Explore topics
- Sales
- Marketing
- Business Administration
- HR Management
- Content Management
- Engineering
- Soft Skills
- See All
