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 worldwide leader in FDA medical device consulting, regulatory compliance, submission, training, and export/import services. They specialize in guiding clients through complex regulatory pathways for medical devices.
**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 worldwide leader in FDA medical device consulting, regulatory compliance, submission, training, and export/import services. They specialize in guiding clients through complex regulatory pathways for medical devices.
**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 providing comprehensive support for medical device regulatory needs. Their services encompass the entire lifecycle from initial submissions to import/export considerations. They emphasize expertise in navigating specific regulatory frameworks such as US FDA, Health Canada, European CE Mark, and Australian ARTG. Buyers seeking assistance with safety and performance testing, or requiring guidance on compliance and submission processes, will find their specialized knowledge valuable.
Key Highlights
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Specializes 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 Health Canada Medical Device License applications.
Source
“Health Canada Medical Device License”
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Offers expertise in European CE Mark compliance.
Source
“European CE Mark”
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Assists with Australia ARTG Inclusion Applications.
Source
“Australia ARTG Inclusion Application”
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Conducts Safety and Performance Testing for medical devices.
Source
“Safety and Performance Testing”
Certifications & Trust Signals
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Regulatory Insight, Inc. is identified as a worldwide industry leader in FDA medical device consulting.
Source
“A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA, Health Canada, CE Mark, or Australian regulatory approval.
- Companies needing assistance with medical device submissions and compliance.
How engagement typically works
- Project-based consulting for specific submissions or compliance needs.
- Guidance on import/export regulations for medical devices.
Typical deliverables
- Completed regulatory submissions (510(k), PMA, De Novo, etc.)
- Compliance strategies and documentation
- Training materials for regulatory processes
- Guidance on safety and performance testing
Good to know
- Best when requiring specialized expertise in medical device regulatory affairs across multiple international markets.
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
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Other
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
