PSEPHOS LIMITED

Clinical and Regulatory service for Software, AI, Apps and Medical Devices

Psephos provide regulatory, clinical and quality assurance services to support cloud-based Software, AI, Machine Learning and Apps ensuring compliance with the current regulations and standards through the product lifecycle including strategy, development, ongoing delivery
(including MHRA reporting), clinical incidents and investigations, vigilance, CAPA procedures, training, QMS and Technical File preparation.

Features

• Software and Apps as a medical device (SAMD)
• Artificial Intelligence (AI) and Machine Learning as a Medical Device
• Quality Management Systems Technical Files (Documentation)
• Clinical Research / Clinical Evaluation / PMCF
• UKCA / UKNI / CE Marking
• Regulatory and Compliance Training
• Internal, supplier, accessibility audits
• Regulatory Compliance
• Risk Management & Clinical Safety Office
• Technical Files (Documentation)

Benefits

• Legal compliance with the regulations
• Clinical safety
• MHRA incident management and mitigation
• CAPA (Corrective and preventative action management)
• Developing compliance software
• Compliance with accessibility requirements
• Usability and user focus
• Reduced bugs and errors on release
• Risk management and control
• Developing internal capability

• Education pricing available

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at jhargreaves@psephos.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 15

Service ID

468717306923242

Contact

Jane Hargreaves
+441273704527
jhargreaves@psephos.com

About the service

• Service categories:

  Cloud Support Services

  Ongoing Support

  • Other

Service scope

• Service constraints: None

User support

• Email or online ticketing support: Yes
• Support response times: Response time dependent on client needs and; also regulatory vigilance requirements. The; support service is part of the review and triage; process run by others.
• User can manage status and priority of support tickets: No
• Phone support: Yes
• Phone support availability: 9 to 5 (UK time), Monday to Friday
• Web chat support: No
• Support levels: This is an additional regulatory triage element within the support function, we would not be the primary support provider, we would work with the primary support provider. Focus is on identifying reportable clinical incidents and managing the vigilance process with MHRA.

Supplier type

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Other security clearance
• Government security clearance: Baseline Personnel Security Standard (BPSS)

Pricing

• Discount for educational organisations: Yes

Cyber security roles

Cyber security governance and risk management

Role level	UK Rate	Offshore Rate
Associate cyber security governance and risk manager	£1,600.00	£1,600.00
Lead cyber security governance and risk manager	£1,800.00	£1,800.00
Principal cyber security governance and risk manager	£3,200.00	£3,200.00

Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2022 certification: No
• ISO 9001 certification: No
• Quality management systems (QMS): Yes
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: Yes
• Cyber Essentials Certificate Number: De879f87-5435-487b-b67c-2435c128ce85
• Cyber essentials plus: No
• Cyber Essentials Alternative: None of the criteria
• Other security certifications: No

Social value

• Mission: Kick start economic growth:

  To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

  Policy Outcome 1: Fair work: That offers fair wages and good working conditions. Help people get a job, stay in work, and progress in their careers, with good employment opportunities across the country. Notes: Where there is a large proportion of labour costs in the contract, commercial teams should consider MAC in Outcome 1 as a priority

  • New or retained jobs on the contract workforce in the relevant area that meet the criteria set out in MAC 1b, 1c and 1d
  • Employment contracts that reflect actual hours worked; steps taken to ensure employees understand their contracts and have the ability to review and adjust them if actual hours regularly exceed contracted hours
  • Payment of more than the National Minimum Wage or National Living Wage (as appropriate) to the contract workforce
  • Measures to support in-work progression to help people in the contract workforce, to move into higher paid work by developing new skills relevant to the contract
  • Understanding of the modern slavery risks and issues affecting the market, industry, sector or country (of origin or of source) relevant to the contract, and the workforce in the supplier’s own organisation and those of its key subcontractors

  Policy Outcome 2: Skills for growth: Supporting growth sectors and addressing skills gaps.

  • Support for educational attainment relevant to the contract, including training schemes that address skills gaps and result in recognised qualifications

  Policy Outcome 3: Resilient, innovative and flexible supply chains: Support economic growth through enabling resilient businesses, opportunities for small businesses and voluntary, community and social enterprises

  • Understanding of the types of businesses in the market and the level of participation by new businesses, entrepreneurs, start-ups, SMEs, VCSEs and mutuals
  • Understanding of local demographics, needs and opportunities for the co-design of the goods, services and works to be delivered under the contract
• Mission: Make Britain a clean energy superpower:

  To cut bills, create jobs and deliver security with cheaper, zero-carbon electricity by 2030, accelerating to net zero

  Policy Outcome 4: Sustainable procurement practices: Reducing carbon footprints, minimising waste, and promoting the use of clean energy and green technologies.

  • Understanding of opportunities for additional environmental benefits delivery in the performance of the contract, including working towards net zero carbon emissions and use of clean energy and green technologies
  • Understanding of how to influence staff, suppliers, customers, communities and/or any other appropriate stakeholders through the delivery of the contract to support climate and nature protection and improvement
• Mission: Break down barriers to opportunity:

  By reforming our childcare and education systems, to make sure there is no class ceiling on the ambitions of young people in Britain

  Policy Outcome 6: Employment and training: For those who face barriers to employment

  • Understanding of employment and skills issues, and of the skills and employment shortages of high growth sectors relating to the contract
  • Understanding of the issues affecting the representation of disabled people in the workforce in the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors
  • Understanding of the issues affecting inequality in employment, skills and pay in the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors. Measures to tackle inequality in employment, skills and pay in the contract workforce

  Policy Outcome 7: Creating a pipeline of opportunities: For the contract workforce, reducing barriers to entry for under-represented groups.

  • Understanding of the issues affecting the development of new skills by target cohort
  • Understanding of issues relating to entering the contract workforce
• Mission: Build an NHS fit for the future:

  That is there when people need it; with fewer lives lost to the biggest killers; in a fairer Britain, where everyone lives well for longer.

  Policy Outcome 8: Increasing productivity through physical and mental wellbeing: In the supply chain and communities in the relevant area.

  • Understanding of issues relating to health and wellbeing, including physical and mental health, in the contract workforce

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at jhargreaves@psephos.com. Tell them what format you need. It will help if you say what assistive technology you use.