Emergo by UL

Is your medical device company ready to enter the Swiss market? Let Emergo by UL be your guide to market entry in Switzerland. Discover the unique advantages of partnering with Emergo by UL: • Liaison excellence: Our role as your Swiss AR means no worries about communication with national authorities • Beyond distribution: Choosing us means getting a partner dedicated to regulatory affairs, not just sales and marketing • Efficiency across time zones: With offices in the US, EU, UK, Canada, Japan, South Korea, Brazil and beyond, get support precisely when you need it Learn more here: https://s.ul.com/3Ld2nwD #medicaldevice #regulatoryaffairs #switzerland #medtech #healthtech #biotech

Looking for customized support to navigate the FDA requirements for your 510(k) submissions? At Emergo by UL, we've got you covered! Our team is dedicated to streamlining your organization's 510(k) submission process, helping you increase efficiency and compliance. Here are the key services we offer: 1. Full 510(k) compilation – whether it's your first 510(k) or you face resource limitations, trust Emergo to: - Confirm that the identified FDA product code and predicate are correct and that all required testing is performed - Conduct a comprehensive gap assessment - Compile all necessary information into a seamless submission 2. 510(k) gap assessment and review: - Evaluate your documentation for acceptability - Identify and address any significant gaps likely to concern the FDA - Conduct an in-depth review of your 510(k) draft Don't miss out on our tailored 510(k) services: https://s.ul.com/3tupNs4

The European AI Act: requirements for high-risk AI systems This is the fourth in our series. As EU institutions gave the Artificial Intelligence Act (AIA) the green light, it seems fitting to conclude our regulatory series with a brief recap and a focus on the high-risk AI systems on which the regulation is mainly concerned. Read more: https://s.ul.com/4f4GsW8 #medicaldevice #regulatoryaffairs #regulatory #update #medtech #AI #EU

Legislation published to delay compliance for legacy IVDs and EUDAMED rollout Additional legislation officially amending the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/745, IVDR) was published as Regulation 2024/1860 on June 13. Learn more here: https://s.ul.com/4f6BA2L #medicaldevice #regulatoryaffairs #regulatory #update #medtech #IVD

Join us live on July 30, 2024, from 9-9:45 a.m. CST for an enlightening session with Ken Pilgrim, our Quality Assurance/Regulatory Affairs manager, on optimizing a quality management system (QMS) for global medical device companies. In this #webinar, the presenter will help attendees better understand the decision points and strategies they might consider when planning upgrades to their QMS to meet new #regulatory requirements. Secure your spot today ➡️ https://s.ul.com/45AITLL

Why do over 15,000 medical device and IVD companies worldwide use the Regulatory Affairs Management Suite (RAMS®) from Emergo by UL to streamline their regulatory affairs and quality assurance processes? Discover the advantages of RAMS: • Simplify your path to global markets with a portfolio of tools designed to make EU MDD, MDR, and IVDR compliance straightforward • IVDR Regulatory Essentials reports help keep your products compliant and competitive • Get timely updates on regulations that matter to your products and automate registration processes to stay ahead of deadlines Take the guesswork out of regulatory compliance and create your complimentary RAMS account today: https://s.ul.com/3xNNtcU #medicaldevice #regulatoryaffairs #regulatorysoftware #RAMS #medtech #healthtech #biotech

See what the human factors lead at a Fortune 500 company has to say about working with Emergo by UL. Learn how our human factors research and design team of experts can help empower your team to develop safer and more useful products: https://s.ul.com/4eV3Wgf #medicaldevice #regulatoryaffairs #medtech #healthtech #pharma #biotech #customerfeedback #testimonial

Ready to bring your medical and IVD products to the U.S. market? You’ll need a trusted U.S. Food and Drug Administration (FDA) Agent to represent your company. Here are some of the many ways Emergo by UL can help you make a splash stateside with minimal hassle: • Global expertise: Leverage our extensive network of specialists dedicated to medical devices and IVDs to support your regulatory strategy across six continents • In-country representation: We can act as your single partner for compliance in over 20 markets worldwide • FDA communications and inspections: Facilitate communications between the FDA and your company to support smooth interactions and inspections of your facilities • Accelerate U.S. market success: Cut down on delays with efficient handling of product inquiries and dedicated support for keeping your compliance goals on track https://s.ul.com/3XQWoov #medicaldevice #regulatoryaffairs #FDA #US #medtech #healthtech #biotech

A structured software development life cycle (SDLC) is critical for increased software safety, reliability and compliance with international standards. Emergo’s SDLC regulatory compliance for medical devices services can help with SDLC compliance in global markets. Learn more: https://s.ul.com/4eXbyyB #RegulatoryAffairs #Compliance #regulatorycompliance #Medtech #software

📢 Last chance to register for our webinar on best practices for engaging with the U.S. FDA on HFE strategy and submission, tomorrow July 11th 2024. 👉 https://s.ul.com/4bkWN5E Emergo by UL’s team provides support throughout the entire process: ✅ Developing a use-related risk analysis, HF validation test protocol and other content for FDA review via pre-submission ✅ Interpreting and developing responses to FDA feedback ✅ Leading HFE-focused discussions with FDA reviewers Register today!