Global Medical Device Consulting – Regulatory, Quality, Clinical | Emergo

Time 2020-07-26 12:08:10

Web Name: Global Medical Device Consulting – Regulatory, Quality, Clinical | Emergo

WebSite: http://www.emergogroup.com

ID:35327

Keywords:

Device,Consulting,Global,

Description:

The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. View All We have deep expertise with a range of product types, including combination and borderline products. A platform of digital products to improve, simplify and automate RA/QA activities LEARN MORE Blog The latest industry news and insights from our global team. View All Resources Resources and tools tailored to medical device professionals. View All MDR Resource Center The knowledge you need for MDR implementation Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR. About Our global consulting team works from 20+ offices on six continents. View All Visit our new resource center to stay informed about global medical device news related to COVID-19. Subscribe to TalkingPoints, a monthly round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more. Europe s new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in mid-2020. Europe's Medical Devices Regulation (MDR) goes into effect in May 2021, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.Pharmaceuticals / BioTechThe demand for combination products continues to grow. We partner with combination product developers to overcome regulatory challenges as well as design safer, more effective products that help deliver more personalized and precise care.LEARN HOW WE HELP Our Services Our experienced staff and global network will provide the support you need. Discovery We can help you explore unmet market needs, innovate with full consideration of commercial goals, and enhance the user experience. Learn more Human factors research & design Apply user-centered design principles through user research, adverse event analysis, usability testing, cognitive walkthroughs, staff training sessions, and more. Learn more Regulatory strategy & gap analysis Plan for rapid global market access with product classification, regulatory pathway selection, technical documentation, and quality management. Learn more Software compliance & security Use regulatory guidance on digital health, wireless compliance, software as medical device (SaMD), and security best practices to succeed with emerging technologies. Learn more Clinical research Assess clinical data requirements for your device and design a clinical strategy that supports your commercialization and product goals. Learn more Risk management Leverage design review, quality management, and clinical data to ensure product safety in line with ISO 14971 and ISO 14155. Learn more Quality management system support Implement and maintain a streamlined QMS in compliance with ISO 13485:2016 and local standards, with internal and gap audits to MDSAP requirements. Learn more Technical file & dossier development Get expert help compiling technical and design documentation tailored to requirements for European CE marking, US FDA 510(k) clearance, and access to global markets. Learn more In-country representation Employ local regulatory expertise to secure market access, conduct clinical trials, and maintain control of your medical device registrations. Learn more Post-market compliance Maintain your position on market with post-market clinical follow-up (PMCF), root cause analysis, incident reporting, and global vigilance support. Learn more Blog The latest industry news and insights from our global team. View All News Get updates about Emergo by UL in the field and in the press. View All Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.

TAGS:Device Consulting Global 

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Emergo: medical device consultants for QA/RA, device registration, clinical trials, reimbursement and distribution consulting. Offices worldwide.

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