Global Medical Device Consulting

We have deep expertise with a range of product types, including combination and borderline products.

Featured Resource

Registration Process | White Papers

Preparing a European CE Technical File for a Medical Device

Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key...

Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.

Learn More

Our team of regulatory, usability, and cybersecurity experts specialize in medical devices and IVDs.

Resources

Meeting FDA expectations for human factors engineering activities

May 16, 2019 | 9am CT FDA has provided industry with guidance on how to...

White paper: Applying human factors to wearable medical devices

The wearable medical device landscape is changing rapidly. An increasing number of medical devices that...

Webinar: Wireless module compliance for medical devices: what you need to know

In our first wireless compliance webinar , we highlighted the two main pathways to medical...

News

Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP) EMERGO BY UL SUMMARY OF KEY POINTS: Japanese regulators extending participation in MDSAP through early...

Regulatory Updates | Medical Devices

New MDCG guidance on timelines and legacy devices in Eudamed

EMERGO BY UL SUMMARY OF KEY POINTS: MDCG explains how to understand Eudamed legislation; Manufacturers...

Regulatory Updates | Medical Devices

Investigational site and personnel selection for medical device clinical studies

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR requirements will affect criteria for medical...

Regulatory Updates | Medical Devices

US FDA issues finalized list of Class I medical device accessories

EMERGO BY UL SUMMARY OF KEY POINTS: FDA finalizes Class I classification for some medical...

We help solve regulatory and compliance problems in the healthcare industry.

Comprehensive service offerings at every point in the product life cycle.

Market Compliance Consulting

Digital Health Consulting

Human Factors Research and Design

Our resource library is tailored to device professionals.

Resource Types

Featured Resource

Registration Process | White Papers

Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.

We accelerate market access worldwide for secure, safe and usable healthcare products.

We have helped 3000+ companies reduce their business risk.

Resources

Meeting FDA expectations for human factors engineering activities

May 16, 2019 | 9am CT FDA has provided industry with guidance on how to...

White paper: Applying human factors to wearable medical devices

The wearable medical device landscape is changing rapidly. An increasing number of medical devices that...

Webinar: Wireless module compliance for medical devices: what you need to know

In our first wireless compliance webinar , we highlighted the two main pathways to medical...

We help solve regulatory and compliance problems in the healthcare industry.

Comprehensive service offerings at every point in the product life cycle.

Market Compliance Consulting

Digital Health Consulting

Human Factors Research and Design

Our resource library is tailored to device professionals.

Resource Types

Featured Resource

Registration Process | White Papers

Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.

Search form

We accelerate market access worldwide for secure, safe and usable healthcare products.

Resources

Meeting FDA expectations for human factors engineering activities

May 16, 2019 | 9am CT FDA has provided industry with guidance on how to...

White paper: Applying human factors to wearable medical devices

The wearable medical device landscape is changing rapidly. An increasing number of medical devices that...

Webinar: Wireless module compliance for medical devices: what you need to know

In our first wireless compliance webinar , we highlighted the two main pathways to medical...