Global Medical Device Compliance and Innovation Consulting by Emergo by UL

Expertise in Global Medical Device Compliance and Innovation

Emergo by UL is a premier consulting firm specializing in global regulatory compliance and factors for medical devices. Our team offers comprehensive services med at facilitating your journey to market and mntning compliance across diverse geographical landscapes.

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With a presence in over 20 countries, Emergo by UL is equipped to help you navigate complex global medical device regulations. Our experienced staff and international network are dedicated to supporting the healthcare and life science industries through various services that enhance product development, market entry strategies, and post-market compliance.

Leverage Our Global Services

Our extensive expertise spans multiple sectors within the healthcare space:

• MedTech: Guiding developers of novel or high-risk medical devices through global regulatory landscapes.

• HealthTech: Supporting tech firms in integrating quality management systems, clinical research requirements, usability studies, and beyond for consumer-oriented connected health solutions.

• Pharmaceuticals BioTech: Assisting combination product developers to overcome challenges across regulatory barriers while focusing on creating safer, more effective personalized care products.

• Healthcare Providers: Facilitating the adoption of tech-based deliverythat improve accessibility without compromising patient safety.

• Health Wellness Retl: Empowering retlers investing in medical devices and health technologies by ensuring compliance with the unique regulatory obligations of both healthcare and devices.

Software Tools and Regulatory Intelligence

Optimize your product development, compliance management, and risk assessment processes with our suite of software tools:

1. RAMS Regulatory Affrs Management Suite: Tlored to assist in navigating EU MDD, MDR, and IVDR regulations with a comprehensive portfolio of services including Product Classification and seven Smart Builders.

2. OPUS Optimal Product Usability Suite: Empowers your team with digital Factors Engineering capabilities through trning, tools, templates, and regulatory guidance to stay ahead in your HFE activities.

Stay Informed

Get the latest insights on global medical device product development and regulatory trs directly from our newsletters: RADAR and TalkingPoints.

Upcoming Events

Join live webinars, workshops, or att trade shows featuring expert-led sessions focusing on various aspects of medical device regulations, compliance strategies, and market access.

Explore Our Resource Centers

Access region-specific market updates, industry trs, white papers, process charts, videos, and consulting services through our dedicated resource centers for Europe, Asia, Latin America, and more:

• Europe: Germany Deutsch, France Fran?s

• Latin America: Brazil Mexico

• Asia: China 简体中文

Partner with Us

To ensure impartiality and protect customer trust and brand integrity, UL Solutions has established processes to identify and manage potential conflicts of interest related to consultancy services for specific regulatory bodies including EU MDD, MDR or IVDD Notified Bodies, UKCA MD Approved Body, and MDSAP.

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For detled information on our cookie policies, privacy guidelines, and how we handle data subject access requests, please visit our online policies page. If you need further assistance, feel free to contact us directly through the provided channels or explore our office locations around the globe.

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