We've helped over 150 software and AI medical devices get to market.
Harness regulatory and market access excellence through our consultancy services by experienced consultants and clinicians within the Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD) industry.
We are a full stack consultancy:
- Target Product Profiling and Value Propositions
- Streamlined and agile FDA and CE/UKCA marking certification
- Quality Management System design for software developers
- Support against all ISO & IEC standards (13485, 14155, 14971, 62304, 82304, 27001, 42001 and more...)
- Trained ISO auditors - mock audits and internal/external audit preparations
- Notified Body and FDA engagement
- Health economic modelling - budget impact and cost-effectiveness/cost-utility
- Market access strategy and competitor analysis
- Clinical evidence, clinical validation and post market clinical follow up
- UKRP and PRRC functions
- Intellectual property management
- Investor due diligence
Got a regulatory problem? We can fix it!
Newsletter: https://www.hardianhealth.com/newsletter
Contact us: https://www.hardianhealth.com/contact
Company Details
- Employees
- 12
- Founded
- -
- Address
- 21 Perrymount Road, Haywards Heath,england Rh16 3ba,united Kingdom
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- hardianhealth.com
- Keywords
- medical devices, SaMD, regulation, health economics, intellectual property, scientific publication, due diligence, AIaMD, clinical investigations, ISO standards, UK DTAC, quality management systems.
- HQ
- Haywards Heath, England
Hardian Health Questions
Hardian Health's website is hardianhealth.com
Hardian Health's LinkedIn profile is https://uk.linkedin.com/company/hardian-health
Hardian Health has
12 employees.
View email and phone details for 12
employees at Hardian Health.
Hardian Health's industry is
Business Consulting and Services
Hardian Health's top competitors are
The Medical Futurist,
Tortus,
Nxgn,
Rock Health,
Future Medicine Ai,
The Abedgraham Group | Abed & Graham Executive Communications,
Assuric,
Scarlet,
Healthtech Pigeon,
Startup Health.
Hardian Health's categories are Business Consulting and Services
Hardian Health's founding year is 2018
