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 Officer

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

£1,200 to £3,200 a unit a day

• 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 14

Service ID

533031068759462

Contact

Jane Hargreaves
+441273704527
jhargreaves@psephos.com

Planning

• Planning service: Yes
• How the planning service works: We offer significant expertise to companies seeking to gain accreditation for software as a medical device (SaMD) in the following areas - UKCA, UKNI, FDA and CE Marking. ; ; Our planning services delivers broadly across four key areas which include a review of the organisation’s current documentation & gap analysis; project implementation; validation and post market follow up to ensure SaMD compliance.; ; Phase 1: Early-Stage Planning; • Determine Intended Purpose ; • Determine Classification; • Determine Conformity Assessment Route; ; Phase 2: Implementation; • Support compliance with Conformity Requirements; • Introduce/enhance Quality Management System; • Support production of Technical Documentation; • Appoint a Person Responsible for Regulatory Compliance; ; Phase 3: Validation ; • Undertake Assessment by a Notified Body; • Prepare and sign Declaration of Conformity; • Obtain QMS and UKCA certificate; • Place UKCA marking on Device; ; Phase 4: Supporting Commercialisation ; • Undertake Post Market Surveillance & Ongoing Assessments
• Planning service works with specific services: No

Training

• Training service provided: Yes
• How the training service works: We provide a suite of regulatory training for inventors of new and innovative medical devices, software, and apps. Our training can be delivered remotely via expert-led webinars, or as on-site classroom based training according to client preference. ; ; Our current training offer under G Cloud 14 can be delivered directly to end-users; using a train-the-trainer approach; or as bespoke executive level regulatory coaching.; ; Topics covered by our training includes:; ; • Navigating the changing regulatory landscape; • Medical Device Regulation/ InVitro Diagnostic Regulation, Technical File, Risk Management and Quality Management Systems ; • Software UKCA marking; • Clinical Evidence ; • Software/AI Medical Device EU MDR CE Marking; • CE Marking and FDA regulations; ; Other regulatory training topics can be commissioned as bespoke training.
• Training is tied to specific services: No

Setup and migration

• Setup or migration service available: Yes
• How the setup or migration service works: We support our buyers as part of our QMS approach to ensure that migration to the cloud or between cloud services with third party agents is mapped and managed as a business-critical step. ; ; We have a dedicated team of software and cloud specialists who manage cloud migration.; ; As part of this capability we provide clients with easy to use, standardised documents to implement change processes associated with set up and data migration, expert consultants who oversee the process and inbuilt steps for software release sign off, extraction and cleansing of data. ; ; These processes include:; ; • cloud readiness assessment which determines the viability of application or data to be migration; • commencement of migration and business and stakeholder impact assessments; • operational acceptance once migrated in new target environment
• Setup or migration service is for specific cloud services: No

Quality assurance and performance testing

• Quality assurance and performance testing service: Yes
• How the quality assurance and performance testing works: We deliver quality and performance testing consultancy services, compliant with standards ISO13485, ISO62304, ISO27001, that help clients develop a regulatory strategy with an action plan for cloud-based services which we can help implement.; ; Quality Management System (QMS) Services to our clients include:; ; • Identification of appropriate QMS standards (e.g. ISO 13485:2016) and regulations (e.g. MDR, UKNI, UKCA) that apply to your company and device; ; • Tiered approach to writing, implementing and operating your QMS; ; • Integrated Document Control and Related QMS Activities Service; ; • Auditing and Corrective Action Planning and Implementation; ; • Training and development of your team to gain the most from the use of your compliant QMS; ; • Risk Management - application of risk management to medical devices (ISO 14971:2019); ; • Post market surveillance as a service, supporting buyers to actively and systematic gather, record and analyse data and implement processes to maintain the safety of the device.

Security testing

• Security services: Yes
• Security services type:
  • Security risk management
  • Cyber security consultancy
  • Security audit services
  • Other
• Other security services:
  • Essential requirements security addressed
  • Regulatory risk assessment

Ongoing support

• Ongoing support service: Yes
• Types of service supported: Buyer hosting or software
• How the support service works: Psephos provide ongoing incident management support, clinical assessment of bugs, fixes, compliance releases, MHRA reporting, and post market surveillance.

Service scope

• Service constraints: None; ; To be expanded - remote and geographical location

User support

• Email or online ticketing support: Email or online ticketing
• 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: 24 hours, 7 days a week
• Web chat support: Web chat
• Web chat support availability: 24 hours, 7 days a week
• Web chat support accessibility standard: None or don’t know
• How the web chat support is accessible: We would ensure compliance with WCAG2.1 ; We integrate with the service providers for this service; We are not the primary web chat platform; we integrate with the web chat platform
• Web chat accessibility testing: This is undertaken by the primary service provider
• 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.

Resellers

• Supplier type: Not a reseller

Staff security

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

Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2007 certification: No
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: Yes
• Cyber essentials plus: No
• Other security certifications: No

Social Value

• Social Value:

  Social Value

  • Fighting climate change
  • Covid-19 recovery
  • Tackling economic inequality
  • Equal opportunity
  • Wellbeing

  Fighting climate change

  Net Zero ; Psephos Biomedica is committed to delivering the net zero agenda and we excel in our green credentials.; ; We operate from an innovation hub in the UK. Our carbon reduction plans extend to:; ; - Our offices - which are easily accessible by public transport networks. We co-locate with Med Tech and FinTech SMEs, sharing the same footprint for meeting space and boardrooms, washroom facilities and cafeteria space. ; ; - Our work-from-home practices - since Covid-19 we have seen a significant reduction in car mileage across the business and we encourage blended working arrangements as part of business-as-usual practices.; ; Promoting Environment Protection and Improvement; ; We have integrated sustainability into our core business operating strategies. We promote environmental/sustainable working practices and behaviour, engaging staff, suppliers and communities to drive sustainability by making greener decisions. These include:-; • Recycling across all our offices; • Implementing ‘paperless’ working practices; • Minimising car travel through home working; • Promoting public transport where face-to-face and onsite meetings are required; • Reducing energy consumption through ‘AAA’ rated appliances/standby functions.; • Following environmentally friendly recycling for electrical goods disposal; • Sourcing replacement laptops and electrical equipment which meet energy saving practices - thereby minimising operating expenses and environmental impact.

  Covid-19 recovery

  Employment, retraining and return to work opportunities ; ; Psephos Biomedica kept the existing workforce in work throughout the Covid-19 period. We invest heavily in our staff, with ongoing training and opportunities to enhance their existing skill sets. In recent years, almost 50% of our staff have been recruited through return-to-work opportunities and we anticipate future growth will include job creation in both highly-skilled and lower-skilled roles. ; To enable us to return to a business-as-usual position, and as a good employer with the health of our staff in mind, we provided and continue to provide access to PPE and hand sanitizer. Staff who have significant physical health conditions or those who continue to ‘shield’, are encouraged to continue to work from home, unless this is impacting their mental health. In addition, we have sought guidance on how to improve staff mental health well-being through our paid memberships of BUPA EAP and The Federation of Small Businesses (FSB). This private healthcare membership directly reduces the demand on NHS health and care services.; ; Workplace Conditions ; As a cloud-based company, our business operating model supports remote working; remote training and remote meeting. We operate a hybrid working policy, with a number of members of staff choosing to work one or two days per week in the office. We continue to monitor Public Health guidance and will continue to do so throughout the lifetime of this framework. Where on-site client visits are required, we complete individual risk assessments, including any relevant Covid-19 Guidelines that are in place at that time, e.g. distancing measures, ventilation etc to reduce likelihood of infection.

  Tackling economic inequality

  Creating new business, new jobs, new skills; ; As part of our growth strategy, we continue to recruit to meet the needs of our business demand. We provide a living wage to all our employees, including those we employed through our apprenticeship scheme, for staff starting in this field, which we pay above the minimum requirement. ; ; For those staff who have changed careers, taken career breaks, or who have been out of the labour market more than five years, we provide flexible working, retraining and upskilling, including training schemes that address skills gaps and result in recognised qualifications.; ; Increase supply chain resilience and capacity ; The primary focus of our consultancy work at Psephos Biomedica is to support businesses to bring new innovation, disruptive technologies and medical, software, web-based platforms and apps into the marketplace and support them to commercialise and scale nationally. ; ; The work we do is supporting industry creation of new businesses, new skills and new jobs within the UK, and for export to the EU, EAA and global markets, and conversely bringing technologies from those global markets into the UK.; ; We work closely with universities, start-ups and Med Tech companies. To support industry growth we offer pro-bono work, free virtual training and reduced rates for charitable organisations, Education, start-ups and not-for-profit organisations. We also make regular charitable giving donations c. 10% of profits per annum to the local communities where we work.

  Equal opportunity

  We are an equal-opportunity employer. We recognise that it is the right of everyone at Psephos to work in an environment that provides equal opportunities for all and is free from any kind of harassment or intimidation. We make every effort to ensure that such an environment is created and maintained and provide equality, fairness, and respect in our employment. ; ; Disabilities friendly employer; As an inclusive employer, we welcome all staff. Our offices are DDA compliant with dedicated disability parking, step-free access, lifts and Radar key accessed toilet facilities. ; ; When recruiting we are committed to making reasonable adjustments for staff. This may include specialist equipment required following DSE risk assessments; flexible hours including 100% work from home; and additional leave requests. ; ; Tackling workforce inequality; As an SME under 250 employees, we are not required to report on annual gender pay gap nor ethnicity pay gap information. However, we know that we appraise, reward, incentivise, promote, train, and commit to the continuing professional development of our workers from a position of fairness. Internal HR analysis confirms that people in our company with comparable jobs have the same rates of pay.; ; In-work progression ; The majority of our workforce is highly skilled. We operate merit-based promotions and support all staff to move to higher-paid work by developing new skills through an annual Performance Development Review process and ongoing training and skills development opportunities. ; ; Our commitment to our workforce extends to our approach towards modern slavery. A copy of which can be requested separately or found on our website.

  Wellbeing

  We recognise stress can be a health and safety issue, and we work to identify and reduce any unnecessary pressure on staff. Managers receive training in good people management practices and our staff handbook and policies set out our approach to supporting the physical and mental wellbeing of our staff. ; ; All staff complete DSE training and risk assessments when working remotely at home and/or in the office to reduce incidences of work-related injuries.; ; We support good workforce mental health by:-; ; • Keeping an eye on workloads/working hours to ensure that people are not overloaded; • Identifying any areas of unnecessary stress through supervisions/Performance Development Reviews ; • Ensuring good communication between people, particularly where there are organisational and procedural changes; • Ensuring all staff understand their duties and responsibilities, and that they are properly trained to do their jobs and given the chance to develop; • Supporting reasonable requests for flexible working and/or home working ; • Encouraging staff to take their full holiday entitlement ; • Preventing bullying and harassment. ; ; We offer extra support to anyone who is going through a difficult time outside work e,g, bereavement/separation. All employees can access the BUPA Employee Assistance Programme which offers support around work, life and health; free confidential advice, and access to a qualified counsellor 24/7. ; ; FSB membership is available to Psephos Directors which provides access to a registered mental health or general nurse for professional advice, guidance and support, as well as therapy services or other appropriate professional help. ; ; Community integration; We are experienced in community, employee consultation and co-design, and will deploy tested methodologies as required.; Psephos operates out of an innovation hub where other tech start-ups and SMEs are based. Staff are encouraged to interact with the local community through events, guest speakers, clinics and workshops.

Pricing

• Price: £1,200 to £3,200 a unit a day
• Discount for educational organisations: Yes

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.