Huma builds regulated Software as a Medical Device (SaMD) solutions
Building a SaMD is complex. Launching it across several continents is even more challenging, but the hardest part is scaling and sustaining it across thousands of hospitals, clinics and patients. When you see our technology, infrastructure and innovation in operation, you will understand why some of the world's biggest life science companies have chosen to use Huma.
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Winner of the 2022 Prix Galien International award for digital health, 'pharma's Nobel prize'1
Active users across
our platforms2
Adherence and retention rates across our care and research deployments3
Devices have been shipped in support of our projects2
Hospitals and clinics use our technologies to make sustainable impacts for patients2
Huma's digital-first health platforms support a network of 27m patients2
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Transforming
healthcare
Registered and able to immediately place products in 33 countries.
Capable of supporting all language requirements.
Self-service modular platform to enable rapid configuration.
"The Most Important Healthcare Design of 2021" by Fast Company
Industry-leading and flexible IoMT integration
We are certified under ISO 27001, Cyber Essentials Plus and we are 21 CFR and GxP compliant
Cloud-agnostic platform that can run on any system
Can be deployed across multiple therapeutic areas
Transforming healthcare and
patient impact with our partners
Registered and able to immediately place products in 33 countries, including the EU, UK, US, Australia, South Africa and Saudi Arabia
Capable of supporting all language requirements with deployments in European languages as well as Arabic and Mandarin or Cantonese
Self-service modular platform to enable rapid configuration of digital health and SaMD products
Selected as a finalist for "The Most Important Healthcare Design of 2021" by Fast Company
Industry-leading and flexible IoMT integration with privileged access to raw data from connected devices
We are certified under ISO 27001, Cyber Essentials Plus and we are 21 CFR and GxP compliant
Cloud-agnostic platform that can run on any system and is currently live on Azure, AWS, Google, Oracle and Alibaba
Can be deployed across multiple therapeutic areas including, cancer, cardiac, metabolic, neurological and respiratory
Orthopaedics,
Diabetes, Heart
health
Connect with us and our partners
We have successfully deployed some of the largest SaMD solutions across multiple patient populations, including heart failure, cardio metabolic disease, pulmonary hypertension and more.
Orthopaedic pathway optimisation
"I got great comfort having the app – it’s like having your very own digital doctor at home!"
SaMD solution for patients living with diabetes
Heart Health
Compliance built-in
EU MDD & MDR
ISO13485
ISO27001
21CFR820 US FDA Class I exempt
IEC/ISO62304
IEC 82304-1
ISO14971
ISO14155
IEC62366
CyberEssentials
CyberEssentials Plus
Approved Pharma Supplier
Regulatory Intelligence
Global Regulatory Footprint
EU MDD & MDR
EC Directive 93/42 and 2017/745 CE Class I
ISO13485
Medical Device ISO Standard & basis for MDSAP
ISO27001
Information Security Management system
21CFR820 US FDA Class I exempt
US Food and Drug Administration Medical Device regulation
IEC/ISO62304
Software Life Cycle Process
IEC 82304-1
Health Software - Part 1: General requirements for product safety
ISO14971
Risk management ISO Standard
ISO14155
Clinical investigation of medical devices for human subjects
IEC62366
Usability Standard for Software as s Medical Device
CyberEssentials
United Kingdom certification scheme for protection in cyber security
CyberEssentials Plus
United Kingdom certification scheme independently validated by an accredited third party
Approved Pharma Supplier
Audited and approved supplier to Major Pharma companies (Bayer, S*N, Janssen, Parexel)
Regulatory Intelligence
Monitoring of global regulatory requirements (EMERGO, Advena, Monitoring of CA websites)
Global Regulatory Footprint
Enabled Market Access by registration with major regulations (US, EU, UK, Middle East, Africa and APAC)
World-leading healthcare
companies partner
with Huma
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Sources
1. Winner of the 2022 Prix Galien International and 2021 Prix Galien USA awards for digital health https://huma.com/announcement/huma-prix-galien-2022
2. Based on internal data, correct as of June 2022
3. Range of data from across a number of Huma projects
4. The telemedicine and call centre functionality is used through the app but is not part of the medical device.
5. https://www.nhsx.nhs.uk/covid-19-response... The full report is available on request.
6. Data from 2021 pilot study. Full evaluation of the service is in preparation
7. Dolezalova, N et al. (2021) Development of an accessible 10-year Digital CArdioVAscular (DiCAVA) risk assessment: a UK Biobank study, European Heart Journal Digital Health https://doi.org/10.1093/ehjdh/ztab057
8. Publication in production