Global Medical Device Consulting

Resources

Conducting a medical device PMCF webinar

REGISTER NOW: Conducting a Medical Device PMCF Study

The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting...

WATCH NOW: Medical Device Registration in Mexico

Mexico is one of the largest medical device importers in the world, making it an...

WATCH NOW: Human Factors Engineering for Combination Products

Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in...

News

US FDA Clarifies Human Subject Requirements for Clinical Investigations EMERGO SUMMARY OF KEY POINTS: New US FDA guidance clarifies compliance requirements for clinical trial...

Regulatory Updates | Medical Devices

Health Canada Developing MDL Policies for 3D-Printed Medical Devices

EMERGO SUMMARY OF KEY POINTS: Health Canada to publish new guidance on MDL requirements for...

Regulatory Updates | Medical Devices

KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS: A new medical device industry survey finds many firms still...

Regulatory Updates | Medical Devices

Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

EMERGO SUMMARY OF KEY POINTS: China’s National Medical Products Administration (NMPA) has expanded its list...

Regulatory Updates | Medical Devices

ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS: The third edition of the ISO 14155 standard...

Regulatory Updates | Medical Devices

US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019

EMERGO SUMMARY OF KEY POINTS: US FDA’s medical device oversight division identifies key guidance publication...

Regulatory Updates | Medical Devices

US FDA Launches Pilot to Expand Special 510(k) Market Pathway

EMERGO SUMMARY OF KEY POINTS: US FDA launching pilot program to expand Special 510(k) route...

Regulatory Updates | Medical Devices

Effects of “No Deal” Brexit for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS: A “no deal” or “Cliff Edge” Brexit is a realistic...

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

Regulatory Compliance | Device Regulations

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

Serving companies that develop products critical to life and well-being

We accelerate regulation-compliant, secure, safe, and usable products to worldwide markets.

More than 3000 companies worldwide trust Emergo. Here's why.

Resources

REGISTER NOW: Conducting a Medical Device PMCF Study

The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting...

WATCH NOW: Medical Device Registration in Mexico

Mexico is one of the largest medical device importers in the world, making it an...

WATCH NOW: Human Factors Engineering for Combination Products

Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in...

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

Regulatory Compliance | Device Regulations

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

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Serving companies that develop products critical to life and well-being

We accelerate regulation-compliant, secure, safe, and usable products to worldwide markets.

Resources

REGISTER NOW: Conducting a Medical Device PMCF Study

The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting...

WATCH NOW: Medical Device Registration in Mexico

Mexico is one of the largest medical device importers in the world, making it an...

WATCH NOW: Human Factors Engineering for Combination Products

Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in...