Global Medical Device Consulting

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MDR Gap Assessment and CE Transition Strategy

Europe's new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in mid-2020.

Does it impact you?

Case Study

Case Study: Ivenix, Incorporated

Use-related risk analysis | User interface design | Instructional material design | Formative and HF validation testing | Regulatory pathway advising

About Us

We are trusted life and health sciences experts

We specialize in global medical device and IVD compliance and innovation. Emergo connects people to safer, more secure services, experiences and environments.

Learn about us

Our Services

Our experienced staff and global network will provide the support you need.

Blog

The latest industry news and insights from our global team. View All

US FDA finalizes guidance for special and abbreviated 510(k) programs

Final guidance for alternate FDA 510(k) market authorization routes, plus updated Refuse to Accept policy

New details from European Commission on Expert Panels under MDR, IVDR

EC sets parameters of expert panel component of MDR, IVDR

European MDR covers cosmetic and aesthetic products: Are these firms ready?

Cosmetic products will need CE Marking to be commercialized in Europe

Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity

Cybersecurity compliance questions medical device manufacturers should be asking

Events

Learn from our experts through live webinars, workshops, and tradeshows. View All

Tradeshow

Market Access

Meet Emergo at RAPS

Sun Sep 22

Tradeshow

Market Access

La rentrée du DM Conference

Wed Sep 25

An intensive look at methods for identifying potential use errors

Webinar

Human Factors Research & Design

An intensive look at methods for identifying potential use errors

Thu Sep 26

News

Get the latest global medical device regulatory news, insights from our experts, and more. View All

South Korean trade group KMDICA teams with Emergo by UL for medical device RA/QA support

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association,...

Meet Emergo at RAPS

La rentrée du DM Conference

An intensive look at methods for identifying potential use errors

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Dutch regulators weigh in on no-deal Brexit impact for medical device companies

FDA issues final guidance on devices containing animal-derived materials

Open session for medical devices in Dublin, Ireland

Getting ready for the EU MDR