Managing Director @HardianHealth We help researchers, industry and investors bring digital solutions to healthcare." title="" class="btn" data-container="body" data-html="true" data-id="156888" data-placement="top" data-toggle="popover" data-trigger="focus" style="color:#b3d4fc" tabindex="0" data-original-title="Hugh Harvey"> 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
18Added in Motherbase
2 years, 11 months agoSoftware & 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
100+ AI products regulatory approved - Software as a Medical Device (SaMD). Regulatory compliance, patents, clinical investigation, market entry, health economics.
Corporate | Type | Tweets | Articles | |
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![]() Microsoft IT services, Software Development | Microsoft IT services, Software Development | Other 2 Oct 2024 | | |
![]() Philips Electricals, Hospitals and Health Care | Philips Electricals, Hospitals and Health Care | Other 3 Jul 2024 | | |
![]() PUBLIC Startup accelerator & VC, IT Services and IT Consulting | PUBLIC Startup accelerator & VC, IT Services and IT Consulting | Other 22 Aug 2023 | | |
![]() SAS IT services, Software Development | SAS IT services, Software Development | Other 9 May 2019 | | |
![]() UK Export Finance National and local authorities, Financial Services | UK Export Finance National and local authorities, Financial Services | Other 25 Feb 2020 | | |
![]() CogX Festival Software Development | CogX Festival Software Development | Other 14 Jun 2018 | | |
![]() Canon Inc. Electricals, Consumer Goods, Retail Office Equipment | Canon Inc. Electricals, Consumer Goods, Retail Office Equipment | Other 12 Mar 2019 | | |
![]() IBM IT services, IT Services and IT Consulting | IBM IT services, IT Services and IT Consulting | Other 23 Mar 2018 | | |
![]() Bayer Pharmaceutical, Chemistry, Chemical Manufacturing | Bayer Pharmaceutical, Chemistry, Chemical Manufacturing | Other 22 Sep 2021 3 Jul 2024 | | |
![]() UK Atomic Energy Authority Research, National and local authorities | UK Atomic Energy Authority Research, National and local authorities | Other 20 Dec 2024 | |