Greenlight Guru

We're #hiring a new Account Executive - CRO/Clinical in Greater Boston. Apply today or share this post with your network.

We're #hiring a new Account Executive in Greater Boston. Apply today or share this post with your network.

Most early-stage MedTech companies tend to follow the 510(k) pathway for market approval in the US. But what about market adoption? 🤔 Just because you don’t need a clinical trial to get your device to market, that doesn’t mean you’ll never need to carry one out. 👀 Then you have to get clinicians to actually use your device—and oftentimes that requires clinical evidence. 🏥 In this article, we're breaking down why your Class II device may need a clinical investigation and what endpoints you should be looking at as you build your study. https://hubs.ly/Q02Vsctv0 #classII #medicaldevices #medtech #greenlightguru #marketaccess #marketadoption #clinicalevidence #fda

Thank you Vincent F. Cafiso for featuring on our Global Medical Device Podcast. 🚀 Vincent is the Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. In this episode, he discusses compliance, quality systems, and MedTech Trends from his 30 years of experience in the field. This is just a snippet, for the full conversation listen to the episode here: https://hubs.ly/Q02Vs79Q0. #podcast #medicaldevicepodcast #greenlightguru #medicaldevices #medtech #research #development

This eBook is an essential resource for any medical device professional looking to confidently manage their QMS and maintain compliance with ISO 13485 standards. Check it out and download here: https://lnkd.in/e2zZrAq6. #iso13485 #qualitymanagement #qms #compliance #medicaldevices #medtech #greenlightguru

📢 𝗔𝘂𝘀𝘁𝗿𝗮𝗹𝗶𝗮𝗻 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗨𝗽𝗱𝗮𝘁𝗲 – 𝗧𝗚𝗔 𝘁𝗼 𝗮𝗰𝗰𝗲𝗽𝘁 𝗨𝗦 𝟱𝟭𝟬(𝗸) 𝗰𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲𝘀 𝗳𝗼𝗿 𝗖𝗹𝗮𝘀𝘀 𝗜𝗜𝗜 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀🎉 𝟮𝟮 𝗢𝗖𝗧: In good news for the medtech industry, an amendment to the Australian legislation was registered on 18 October, with effect from 19 October, allowing ARTG applications for Class III medical devices to be supported by US FDA 510k clearances. Such ARTG applications must also be supported by an MDSAP QMS certificate. Previously, the only US FDA evidence accepted as supporting evidence for Class III devices was a PMA. The amendment also allows Class IIa devices which are 510k exempt in the US to be supported by MDSAP QMS certification only. Previously all ARTG applications for Class IIa devices required 510k clearance as evidence of product assessment (if relying on US FDA evidence). ⚠️𝙉𝙤𝙩𝙚: unlike Class III medical devices supported by a US FDA PMA, those supported by an MDSAP certificate and 510k clearance 𝙢𝙪𝙨𝙩 𝙪𝙣𝙙𝙚𝙧𝙜𝙤 𝙖 𝙢𝙖𝙣𝙙𝙖𝙩𝙤𝙧𝙮 𝙏𝙂𝘼 𝙖𝙥𝙥𝙡𝙞𝙘𝙖𝙩𝙞𝙤𝙣 𝙖𝙪𝙙𝙞𝙩 prior to ARTG inclusion. Link: https://lnkd.in/g3Au7kp5   #TGA #MedicalDevices #RegulatoryReliance #AlwaysEvolving 

Did you know that over 60% of medical device quality issues stem from ineffective CAPA processes, and nearly half of all FDA warning letters cite deficiencies in risk management? 😟 CAPA and risk management are not just regulatory requirements but essential components of ensuring product safety and compliance in the medical device industry. Join this upcoming webinar, led by our partner Rook Quality Systems, and learn: 📌 The connection between risk management and CAPA in medical device quality, 📌 How to leverage CAPA data to enhance your risk management process, 📌 Practical steps for integrating risk management and CAPA within your QMS, 📌 Best practices for identifying, mitigating, and tracking risks through CAPA, 📌 Case studies demonstrating successful risk management and CAPA integration. Register now: https://hubs.ly/Q02V3HCp0. #capa #riskmanagement #qms #qualitymanagement #webinars #fda #regulations #greenlightguru

We're #hiring a new Product Marketing Director in Greater Boston. Apply today or share this post with your network.

We're #hiring a new Associate General Counsel in Atlanta Metropolitan Area. Apply today or share this post with your network.

Are you working on a combined study in the EU or looking to start one? Then you're most likely facing a big challenge: getting a separate approval for drug clinical trials and IVD clinical performance studies and/or medical device clinical investigations as well as dealing with separate regulatory authorities. 😟 Not to mention that EUDAMED, the European-wide medical device database, is still under development... These concerns prompted the initiation of the COMBINE project to better understand and analyze the issues faced and to find ways to address these, with a goal of encouraging continued combined studies in Europe. Learn more about this project in this article from our partner PharmaLex: https://hubs.ly/Q02Tp45S0. #combine #eudamed #eumdr #ivd #clinicalinvestigation #clinicaltrials #combinedstudy #medicaldevices #medtech #greenlightguru