Testing and Validation

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.
  
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  Resource Types
  
  Market Data
  
  White Papers
  
  Videos
  
  Webinars
  
  Process Charts
  
  Device Regulation
  
  Service Overviews
  Featured Resource
  
  Regulatory Compliance | Service Overviews
  
  Medical Device Consulting Services for Hong Kong
News
About
- Our global consulting team works from 20+ offices on six continents. Let us help you expand your reach.
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  Market Compliance Consulting
  
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  Certifications
  Our team of regulatory, usability, and cybersecurity experts specialize in medical devices and IVDs.

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 | Service Overviews

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

We offer biocompatibility, shelf-life, and other non-clinical tests to ensure your device meets regulatory expectations.

Testing and Validation

Questions? Request more information from our specialists

Q1 Combination Product Regulation Conference, Feb 28, 2019 to Mar 1, 2019 in Arlington, USA

Testing and Validation

US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices

Testing and Validation

New US FDA Recommendations for Non-Clinical Bench Performance Test Submissions

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 | Service Overviews

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

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We offer biocompatibility, shelf-life, and other non-clinical tests to ensure your device meets regulatory expectations.

Testing and Validation

Questions? Request more information from our specialists

Q1 Combination Product Regulation Conference, Feb 28, 2019 to Mar 1, 2019 in Arlington, USA

Testing and Validation

US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices

Testing and Validation

New US FDA Recommendations for Non-Clinical Bench Performance Test Submissions