Global Medical Device Consulting

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REGISTER 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...

WHITE PAPER: The New India Medical Device Rules, 2017

India has made significant strides in the healthcare sector in the past few decades. In...

News

India Medical Device and IVD Regulatory Update: September 2018 EMERGO SUMMARY OF KEY POINTS: India’s Central Drugs Standard Control Organization (CDSCO) plans to rename...

Regulatory Updates | Medical Devices

US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary...

US Regulators Plan Overhaul of Third-Party 510(k) Review Program

EMERGO SUMMARY OF KEY POINTS: US FDA is amending its 510(k) third-party review program 3PRO...

Regulatory Updates | Medical Devices

US FDA Proposes Single, Electronic Submissions for Medical Device Market Applicants

EMERGO SUMMARY OF KEY POINTS: US FDA wants only electronic submissions for most medical device...

Regulatory Updates | Medical Devices

Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers

EMERGO SUMMARY OF KEY POINTS: Health Canada’s Pre-Clinical Meeting program to provide feedback and...

Regulatory Updates | Medical Devices

US FDA Rolls Out Pilot for Simplified 510(k) Submissions

EMERGO SUMMARY OF KEY POINTS: US FDA has launched a pilot program for streamlined 510(k)...

Regulatory Updates | Medical Devices

MDR Analysis: Does your medical device fall under the scope of new European regulations?

Now that the European Medical Device Regulation (MDR) is widely available, manufacturers and other industry...

Regulatory Updates | Medical Devices

Brazil’s ANVISA Readies Regulations for Custom-made Medical Devices

EMERGO SUMMARY OF KEY POINTS: ANVISA rolling out new regulations for custom-made medical devices Requirements...

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

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

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Our resource library is tailored to device professionals.

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Resources

REGISTER 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...

WHITE PAPER: The New India Medical Device Rules, 2017

India has made significant strides in the healthcare sector in the past few decades. 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

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

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We help companies bring safer, better products to market faster while reducing regulatory risk.

Resources

REGISTER 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...

WHITE PAPER: The New India Medical Device Rules, 2017

India has made significant strides in the healthcare sector in the past few decades. In...