Entity
  • Hardian Health

    Created in 2018
  • BETA

    Up & running (A)
    Existing signals show a regular activity
  • Social networks

    12,381 1,398 3,467
  • Activities

  • Technologies

  • Entity types

  • Location

    Cassidy Davis Insurance Services Ltd, 21 Perrymount Rd, Haywards Heath RH16 3TP, UK

    Haywards Heath

    United Kingdom

  • Employees

    Scale: 11-50

    Estimated: 14

  • Engaged corporates

    18
    3 10
  • Added in Motherbase

    2 years, 11 months ago
Description
  • Value proposition

    Software & AI as Medical Device | CE,UKCA, FDA | QMS | ISO & IEC standards | Clinical Validation | Health Economics | IP

    We help researchers, industry and investors bring digital solutions to healthcare.

    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
    - FDA and CE/UKCA marking certification
    - Quality Management System design, development and deployment
    - 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

    Newsletter: https://www.hardianhealth.com/newsletter
    Contact us: https://www.hardianhealth.com/contact

    medical devices, SaMD, regulation, health economics, intellectual property, clinical trials, scientific publication, due diligence, and AIaMD

  • Software as a Medical Device Consultancy | Hardian Health

    100+ AI products regulatory approved - Software as a Medical Device (SaMD). Regulatory compliance, patents, clinical investigation, market entry, health economics.

  • https://www.hardianhealth.com/
Corporate interactions BETA
Corporate TypeTweets Articles
Microsoft
Microsoft
IT services, Software Development
Microsoft
IT services, Software Development
Other

2 Oct 2024


Philips
Philips
Electricals, Hospitals and Health Care
Philips
Electricals, Hospitals and Health Care
Other

3 Jul 2024


PUBLIC
PUBLIC
Startup accelerator & VC, IT Services and IT Consulting
PUBLIC
Startup accelerator & VC, IT Services and IT Consulting
Other

22 Aug 2023


SAS
SAS
IT services, Software Development
SAS
IT services, Software Development
Other

9 May 2019


UK Export Finance
UK Export Finance
National and local authorities, Financial Services
UK Export Finance
National and local authorities, Financial Services
Other

25 Feb 2020


CogX Festival
CogX Festival
Software Development
CogX Festival
Software Development
Other

14 Jun 2018


Canon Inc.
Canon Inc.
Electricals, Consumer Goods, Retail Office Equipment
Canon Inc.
Electricals, Consumer Goods, Retail Office Equipment
Other

12 Mar 2019


IBM
IBM
IT services, IT Services and IT Consulting
IBM
IT services, IT Services and IT Consulting
Other

23 Mar 2018


Bayer
Bayer
Pharmaceutical, Chemistry, Chemical Manufacturing
Bayer
Pharmaceutical, Chemistry, Chemical Manufacturing
Other

22 Sep 2021

3 Jul 2024



UK Atomic Energy Authority
UK Atomic Energy Authority
Research, National and local authorities
UK Atomic Energy Authority
Research, National and local authorities
Other

20 Dec 2024


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