WCG’s Post

Did you know that AQC members drive efficiency in clinical trials with access to 1,500+ member resources? Tools, templates, and metrics that can be customized for your organization to streamline processes and ensure inspection readiness are available to all members at a cost significantly less than if this material was sourced through consulting engagements, conferences, and individual research. Each resource is developed through rigorous research and review by WCG subject matter experts and continuously updated as industry needs evolve. Join 225+ member organizations – including sponsors, providers, and sites – with the shared objective of elevating quality in clinical trials. Contact us to get involved in the AQC today: https://lnkd.in/dzU8_eXA #WCG #AQC #ClinicalTrials #ClinicalResearch #Consortium #LeadingPractices

An interesting session on QSMR by Michelle Lott, RAC and MedTech Leading Voice. These steps will help the #US #MedTech companies align with and comply with relevant regulations regarding quality management. #USFDA #MDSAP #MedicalDevices

📢 NoBoCap project offering C-level program on MDR/IVDR implementation   🇪🇺 Are you seeking insights into navigating the European regulatory landscape for medtech products? Sign up for NoBoCap Project’s free program on #MDR / #IVDR implementation and resource and budget allocation, adapted for C-level management. 🗓 The program kicks off on 17 May with a half-day seminar. It continues weekly with one-hour webinars and culminates in a second half-day seminar. The in-person seminars are in #Ghent. 👨💼 Marketing medtech products in Europe's highly regulated landscape 💻 Investments need to bridge Europe’s “regulatory valley of death” 💻 Selecting a Notified Body for your medtech product 💻 Developing quality management systems and documentation 💻 Start-up case study on investing at the right time 👩💼 Exchange experiences on challenges, successes and progress 𝗠𝗼𝗿𝗲 𝗶𝗻𝗳𝗼 & 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿! 👉🏾 https://lnkd.in/dpZHWTg2

Just recently, EUDAMED received another timeline update: a three-year extension. The development of the module for Clinical Investigation and Performance Studies (CI/PS) will take longer than expected. The new date of EUDAMED's full functionality is Q2 of 2027. Dates which are much more important for you as a future user of the EUDAMED: - Q4 2027 – mandatory use of the Actor, Market Surveillance, Vigilance, and CI/PS modules  - Q2 2029 – mandatory use of the Device and Certificates modules For a more detailed overview, look at the EU's roadmap here.

cGMP Dialogues: Challenges in compliance? We at Amicus have solutions tailored for you. Drop by Booth #6, and let's pave the path to seamless compliance together! #pda #amicus #fda #gmp #regulatoryaffairs #riskmanagement #pharma https://zurl.co/yZOT

With cross-functional awareness contributing to 69% of perceived RBQM adoption challenges, Ken Getz from Tufts Center for the Study of Drug Development covered who's most likely resisting RBQM in your organization, why, and solutions to implement that might just stimulate adoption. Check out the executive roundtable to catch up. ✅ Watch the recording: https://bit.ly/3tjUz6w #RBQM #RiskManagement #ClinicalTrial

I will be giving a full summary of every part of this guidance that has changed in Rev 1. Join us for this webinar to stay up to date. https://lnkd.in/e-hvDd3c #PRRC #MDCG #MDR #IVDR #medicaldevices

MSD in name only? What kinds of questions could you ask at the program level to determine whether or not you are truly implementing a #MarketSystems development program? A while back and with the help of #MSD experts Mike Klassen, Samira Saif and Kelsey Bachenberg we developed a set of litmus test questions. BEAM Exchange Marketlinks #USAID #DFAT #InternationalDevelopment #MarketSystems

Meet Martina Krumbiegel, a key player at Kalms Group, specializing in Article 13. MDR & IVDR. 🔍 With a recent bachelor's degree in business management, and ongoing MBA, she's the pillar of Kalms Operations. 🛠 Project Navigation from Scratch! Martina excels in coordinating projects from inside out, showcasing expertise honed through successful ventures, tackling the intricacies of the medical device industry. 🔬 Expert in Art. 13 MDR & IVDR marketability! Beyond ticking boxes, Martina commits to seamless regulatory compliance, from language nuances to correct labelling, ensuring your peace of mind. 🏆 Overcoming Challenges! Thriving on challenges, Martina's expertise shines in labelling of all classes of medical devices and IVDR products, paving the way for your business effortlessly. 💡 How Can Martina’s Expertise Elevate Your Business? 1️⃣ MDR & IVDR Compliance Assurance: Exceeding regulatory standards, ensuring your business's compliance journey is exceptional. 2️⃣ Strategic Project Coordination: Orchestrating projects to perfection, guaranteeing timely delivery and unparalleled quality. 3️⃣ Navigating Challenges: Your guide through the maze of challenges when placing medical devices on the market in the European Economic Area. 4️⃣ Seamless Tracing and Surveillance: With Kalms Operations, your business effortlessly complies with product tracing and post-market surveillance obligations. 🌐 Connect with Martina and Kalms Operations! Where compliance isn't just a requirement but a strategy for success. #MDR #IVDR #Healthcare #HealthcareConsulting #ComplianceExcellence #LinkedInCommunity 🌐 

In for the home stretch at #AAPSPharmSci360 here in Orlando (last full day). For those of you still here, please join me for my Rapid Fire talk at 3:15 (205 AB West)! Session: Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1 Hierarchical Approach to Raw Material Variability in Drug Product Lifecycle