Russell Regulatory Consultants’ Post

Comparing SaMD Regulations - USA vs EU & Key Features Explained Explore the key differences between US FDA and EU MDR regulations for Software as a Medical Device (SaMD), including classification, submissions, and regulatory requirements. https://lnkd.in/g3yRR-Xt #samd #eumdr #regulatoryrequirements 

🎓 🎓 Register for the free introductory module of our online course Medical Device Design & Development for New & Legacy Products next January 15. 💻 💻 During this module, you will gain an overview of regulatory requirements and routes to market and touch on key themes such as the MDR and the EU and FDA landscapes. #educolifesciences #legacyproducts #medicaldevices #mdr #medicaldevicetraining

One of our regulatory affairs consultants, Emma Knijn, discusses the first steps that SaMD manufacturers should take when undergoing medical device EU market entry. Explore our most recent video, which delves into the intricacies of medical device manufacturing, with a specific focus on the challenges associated with obtaining a CE marking. Gain valuable insights into the key questions faced by SaMD manufacturers in ensuring MDR compliance, along with best practices for a streamlined entry into the EU market. Click here to view the full video: https://lnkd.in/gY6XVCpi #RegulatoryExperts #RegulatoryAffairs #MedEnvoy

📢 Navigating the FDA 510(k) submission process can be challenging, but we're here to make it easier! Check out our latest YouTube video for a step-by-step guide on how to prepare and submit a successful 510(k) for medical device clearance. Whether you're new to regulatory affairs or looking to streamline your process, this video has practical tips to get you on the right path. Watch now: https://lnkd.in/egNKFm4D #FDA #510k #RegulatoryAffairs #MedicalDevices #PrimePathMedtech

🚀 MORE Exciting News! 🚀 We’re thrilled to share our case study showcasing how CLIN-r+ supported a leading American manufacturer of guidewires and catheters in transitioning from FDA 510(k) to EU MDR compliance. Our collaboration enabled their ‘Vascular Access’ business unit to prepare for the European market by leveraging existing FDA 510(k) files to create EU MDR Technical Documentation for CE marking. By outsourcing this critical process, the manufacturer could focus on their core operations while ensuring a smooth and timely regulatory transition. Discover how our strategic partnership resulted in cost reductions, streamlined processes, and a successful EU MDR submission well ahead of schedule, and see how CLIN-r+ can help your organization achieve regulatory excellence and market expansion: https://lnkd.in/eDWtrnpU #MedTech #MDR #FDA510k #RegulatoryCompliance #MarketExpansion #HealthcareInnovation #strategicpartnership #eumdr #cemarking #technicaldocumentation #medicaldevice #regulatoryaffairs #regulatorycompliance #euregulation

This document provides crucial guidance on implementing the Master UDI-DI solution for contact lenses under the EU Medical Device Regulation (MDR) 2017/745. Key points: 1. Purpose: To guide manufacturers, importers, and distributors in properly implementing Master UDI-DI requirements for contact lenses, which are considered "highly individualized devices." 2. Regulatory Framework: Based on the EU MDR 2017/745 and amended by Commission Delegated Regulation (EU) 2023/2197. 3. Technical Specifications: Outlines the structure, format, and data elements required for the Master UDI-DI, adhering to ISO/IEC 15459 standards. 4. Implementation: Covers the process of requesting and obtaining a UDI-DI from an issuing entity and submitting data to EUDAMED. #medicaldevices #regulatoryaffairs #mdr

"Excited to share that I’ve successfully completed a mini-course on MDR 2017/745, deepening my understanding of the European Medical Device Regulations! This course has strengthened my knowledge of compliance and regulatory standards in the medical device industry. Special thanks to Monir El Azzouzi for the valuable insights!Looking forward to applying this expertise in my future regulatory affairs endeavors. #MDR2017 #MedicalDevices #RegulatoryAffairs #LearningAndDevelopment"

In today's evolving regulatory landscape, staying ahead of changes is vital for medical device companies aiming to ensure quality and compliance. With shifting FDA guidance and the EU MDR, companies are tasked with navigating complex requirements to keep their products market-ready. Staying informed and agile can turn these challenges into opportunities, reinforcing trust and safeguarding patient outcomes. For MedTech companies, regulatory agility isn't just about meeting standards, it's a competitive advantage and we're here to help. Learn more at https://lnkd.in/e-Mm2z88 #RegulatoryCompliance #WorldQualityWeek #MedicalDeviceManufacturing

To learn about the latest FDA requirements for the US market.Join our exclusive webinar #DQS#learning#gain knowledge

🔍 Introducing our FAQ on compiling your Device #TechnicalDocument under EU MDR! Curious about how to structure and the content of the TD their importance under the EU Medical Devices Regulation? Our FAQ covers everything you need to know, including: ✅ How to structure a TD to be compliant. ✅ What content should be in each section ✅ How does it differ form the MDD and a FDA dossier. ✅ The role of harmonised standards and validation testing. Gain insights into how a well-structured #TechnicalFile can streamline your products #MDR #CE assessment. That can fast track your device development, ensure regulatory compliance, and facilitate market entry. https://lnkd.in/eu2Rpivc