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 providing regulatory insight and human factors testing 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 Application
* Safety and Performance Testing
* Medical Device Importing/Exporting
**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 providing regulatory insight and human factors testing 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 Application
* Safety and Performance Testing
* Medical Device Importing/Exporting
**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. Their services encompass a broad range of needs, from initial submissions to ongoing compliance and international trade. They emphasize expertise in areas such as US FDA 510(k) and PMA processes, Health Canada licensing, European CE marking, and Australian ARTG inclusion. Additionally, they offer support for safety and performance testing, as well as medical device importing and exporting. Buyers seeking assistance with navigating global regulatory requirements for medical devices will find a comprehensive suite of services designed to ensure compliance and facilitate market access.
Key Highlights
-
Specializes in US FDA 510(k), PMA, and De Novo submissions.
Source
“US FDA 510(k), PMA, De Novo”
-
Provides services for European CE Mark compliance.
Source
“European CE Mark”
-
Offers support for Australia ARTG Inclusion Applications.
Source
“Australia ARTG Inclusion Application”
-
Expertise in Medical Device Importing/Exporting.
Source
“Medical Device Importing/Exporting”
Certifications & Trust Signals
-
A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services.
Source
“A Worldwide Industry Leader in FDA Medical Device Consulting, Regulatory Compliance, Submission, Training, Export & Import Services”
Buyer Snapshot
Best for
- Companies seeking FDA medical device approval
- Manufacturers needing international regulatory compliance
- Firms requiring assistance with medical device submissions
How engagement typically works
- Project-based consulting
- Expert guidance on regulatory pathways
Typical deliverables
- Regulatory submission packages (510(k), PMA, De Novo)
- CE Mark documentation
- ARTG inclusion applications
- Import/Export compliance strategies
Good to know
- Best when requiring specialized expertise in FDA and international medical device regulations.
HQ:
US
Languages:
English
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
Services Offered:
User interface evaluation, Validation testing
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Participant Recruitment Details:
Please send inquiries directly to the Contact person listed on each Service page. To look up an individual office, view our locations. Please go to People Search to find lawyers by name, location or expertise. Or use site search. Please go to Careers for lawyer recruitment, student/graduate recruitment and all other job/internship inquiries. To look up an individual office, view our career locations.
Rush Available:
No
Nda Support:
Yes
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
Custom
Pricing Model
Custom
