Regulatory Insight
White & Case LLP
White & Case LLP is a global law firm advising clients on complex legal matters, including M&A, energy, and technology. They offer expertise in regulatory insight and human factors testing.
White & Case LLP is a leading international law firm with a global presence, recognized for its legal innovation and outstanding client service. They advise clients on a wide range of complex legal issues, including major transactions, regulatory matters, and emerging technologies. Their expertise spans areas such as M&A, energy, data centers, and the legal implications of AI and digital transformation. The firm is committed to providing strategic legal counsel that aligns with clients' business objectives, particularly in navigating evolving global trends and regulatory landscapes. White & Case LLP offers specialized services relevant to usability and human factors testing through their deep understanding of regulatory frameworks and technological advancements.
About
**Who they are**
Regulatory Insight, Inc. is a global leader in FDA medical device consulting, regulatory compliance, submission, training, and export/import services. They specialize in providing expertise for medical device regulatory needs.
**Expertise & scope**
* US FDA 510(k), PMA, De Novo submissions
* Health Canada Medical Device License applications
* European CE Mark compliance
* Australia ARTG Inclusion Applications
* Safety and Performance Testing
* Medical Device Importing/Exporting
* Medical Device Consulting
* Medical Device Compliance
* Medical Device Submission
* Medical Device Training
**Reputation / proof points**
* A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services
Regulatory Insight, Inc. is a global leader in FDA medical device consulting, regulatory compliance, submission, training, and export/import services. They specialize in providing expertise for medical device regulatory needs.
**Expertise & scope**
* US FDA 510(k), PMA, De Novo submissions
* Health Canada Medical Device License applications
* European CE Mark compliance
* Australia ARTG Inclusion Applications
* Safety and Performance Testing
* Medical Device Importing/Exporting
* Medical Device Consulting
* Medical Device Compliance
* Medical Device Submission
* Medical Device Training
**Reputation / proof points**
* A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services
Additional information
Regulatory Insight focuses on guiding clients through the complexities of medical device regulatory pathways. They offer services that span the entire lifecycle of a medical device, from initial submission and compliance to ongoing training and international trade. Their approach aims to streamline the process for manufacturers seeking approval and market access in various global regions. Buyers can expect a comprehensive service offering designed to address specific regulatory challenges.
Key Highlights
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Worldwide industry leader in FDA medical device consulting, regulatory compliance, submission, training, and export/import services.
Source
“A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services”
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Offers expertise in US FDA 510(k), PMA, and De Novo submissions.
Source
“US FDA 510(k), PMA, De Novo”
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Provides support for international regulatory requirements including Health Canada, European CE Mark, and Australia ARTG.
Source
“Health Canada Medical Device License, European CE Mark, Australia ARTG Inclusion Application”
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Services include safety and performance testing for medical devices.
Source
“Safety and Performance Testing”
Certifications & Trust Signals
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Regulatory Insight, Inc. has been providing comprehensive medical device consulting and compliance services.
Source
“Regulatory Insight, Inc. | A Worldwide Leader In FDA Medical Device Consulting, Compliance, Submission, Training and Export/Import Services”
Buyer Snapshot
Best for
- Companies needing legal counsel on complex M&A, energy, or technology matters.
- Organizations requiring expertise in regulatory insight.
- Businesses seeking human factors engineering and testing services.
How engagement typically works
- Legal advisory services.
- Specialized consulting for regulatory compliance.
- Human factors engineering and testing.
Typical deliverables
- Legal opinions and strategies.
- Regulatory compliance assessments.
- Human factors testing reports.
Good to know
- Best when clients have complex legal and regulatory challenges in M&A, energy, or technology sectors.
HQ:
Nashville, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, Canada, Japan, Australia, Brazil, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study, Both
Services Offered:
Risk analysis, Validation testing
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance, ISO 14971
Has Participant Recruitment:
Yes
Participant Recruitment Details:
Regulatory Insight has provided comprehensive worldwide regulatory medical device consulting services to over 700 global clients in the medical device and IVD industries, ranging from small-scale start-up companies to established Fortune 500 corporations.
Rush Available:
No
Nda Support:
Yes
User Types Supported:
Professional healthcare
Use Environments Supported:
Professional healthcare
Has Usability Lab:
No
Has Remote Testing:
No
Minimum Project Size:
$50k+
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Regions Served:
Worldwide
Additional usability_human_factors_testing Details
Usability Study Types Offered
Both
Services Offered
Human factors testing
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971, Other
User Types Supported
Lay user, Professional healthcare, Both
Use Environments Supported
Home healthcare, Professional healthcare, Both
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Minimum Project Size
No minimum
Pricing Model
Custom
