Global Medical Device Consulting

Expertise
- We help solve regulatory and compliance problems in the healthcare industry.
  
  Expertise Overview
  Combination Products
  
  Digital Health Products
  
  Health and Wellness Products
  
  In-Vitro Diagnostic Devices
  
  Medical Devices
  
  Retail
  We have deep expertise with a range of product types, including combination and borderline products.
Services
- Comprehensive service offerings at every point in the product life cycle.
  
  Services Overview
  
  Services by Market
  Market Compliance Consulting
  
  Device Registration
  
  In-Country Representation
  
  Regulatory Consulting
  
  CRO Services
  
  QMS Compliance
  
  Post-Market Surveillance
  Digital Health Consulting
  
  Cybersecurity Risk Management and Procurement Support
  
  FDA Cybersecurity Guidance Consulting
  Human Factors Research and Design
  
  Research
  
  Analysis
  
  Design
  
  Evaluation
  
  Training
Resources
- Our resource library is tailored to device professionals.
  
  View all resources
  Resource Types
  
  Market Data
  
  White Papers
  
  Videos
  
  Webinars
  
  Process Charts
  
  Device Regulation
  
  Service Overviews
  Featured Resource
  
  Regulatory Compliance | White Papers
  
  European Clinical Investigation of Medical Devices
  
  Clinical Investigations or studies are easily the most expensive and time–consuming endeavors undertaken by a medical device manufacturer on the path to CE Marking. Errors...
News
About
- Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.
  Learn More
  Overview
  Market Compliance Consulting
  
  Digital Health Consulting
  
  Human Factors Research and Design
  
  Careers
  
  Locations
  
  Events
  
  Certifications
  Our team of regulatory, usability, and cybersecurity experts specialize in medical devices and IVDs.

Resources

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 | 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

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

April 11, 2019 | 9am CT In our first wireless compliance webinar , we highlighted...

White paper: Medical device registration in Singapore

Interested in selling your medical device in Singapore? Singapore is a leading healthcare destination in...

Webinar: GDPR and its impact on Human Factors studies

The General Data Protection Regulation (GDPR) became the law in Europe as of May 25,...

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 | 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

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

April 11, 2019 | 9am CT In our first wireless compliance webinar , we highlighted...

White paper: Medical device registration in Singapore

Interested in selling your medical device in Singapore? Singapore is a leading healthcare destination in...

Webinar: GDPR and its impact on Human Factors studies

The General Data Protection Regulation (GDPR) became the law in Europe as of May 25,...