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DPM DIGITAL HEALTH CONSULTANCY LTD

Digital Health regulatory compliance services

Digital Health technologies regulatory compliance consultancy services which include Clinical Safety (DCB0129/0160), DTAC compliance, Medical Devices Regulations (UK/International) including Quality Management System and ISO implementation (ISO13485, 14971, 62304). Clinical Risk Management training and Clinical Safety Officer mentorship. Our team have comprehensive experience in implementing digital health systems into the NHS.

Features

  • Clinical Risk Management regulatory compliance service (DCB 0129 & )160
  • Appointed Clinical Safety resource including Clinical Safety Officer(s)
  • Digital Technology Assessment Criteria (DTAC) compliance and audit support
  • Development and implementation of an operational Clinical Risk Management System
  • Clinical Safety Officer mentorship programme utilising an adapted GROW methodology
  • Clinical Risk Management training eLearning, bespoke, virtual, Onsite (CPD accredited)
  • Digital Health regulatory pathway with market access advice and guidance
  • Artificial Intelligence Management System development and implementation aligned with ISO42001
  • Medical Device Regulatory services including compliance, audit and maintenance
  • Information Security, Governance and Cybersecurity compliance service

Benefits

  • Compliance with NHS digital clinical safety standards utilising competent resources
  • Experienced Clinical Safety Officer allocation and resourcing to support projects
  • Digital Health regulatory compliance strategy and certification requirements completion
  • Ability to scale resources depending on the organisations requirements
  • Providing mentorship and training to sustain Clinical Risk Management processes
  • Effective Clinical Risk Management processes supporting the delivery of care
  • Health sector knowledge bringing fresh insights and perspective to projects
  • Support existing Clinical Risk Management processes and enhancing efficiencies
  • Improvement of organisational quality management processes through agile implementation
  • Support the organisation with AI standards BS42001 and BS30440

Pricing

£650 to £750 a unit a day

Service documents

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 dean.mawson@dpmdigitalhealth.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

8 5 1 3 3 8 3 8 6 7 2 3 7 7 0

Contact

DPM DIGITAL HEALTH CONSULTANCY LTD Dean Mawson
Telephone: 07840049772
Email: dean.mawson@dpmdigitalhealth.co.uk

Planning

Planning service
No

Training

Training service provided
Yes
How the training service works
Our team can provide on-site or virtual bespoke Clinical Risk Management training that covers all aspects of the Clinical Risk Management process allowing your team members to interact with and manage the Clinical Risk Management System and process. The training can be tailored to meet your needs as an organisation depending on the project(s) that require supporting.

Our courses tackle the operational aspects of Clinical Risk Management both complimenting the NHS England courses or as a masterclass supporting all your Clinical Risk Management needs.

Clinical Safety Awareness Training – a team member will provide a 4 hour overview of the NHS safety standards DCB0129/DCB0160 and the complete Clinical Risk Management process. This allows you to invite as many people as you wish so that all relevant team members are aware of their role and responsibility when integrating Clinical Risk Management into the organisations existing processes which includes a hazard workshop scenario that we walk through as a group.

Clinical Risk Management Training – a team member will provide a fully comprehensive Clinical Risk Management course to those team members who will be directly involved and responsible for Clinical Risk Management in compliance with DCB0129/DCB0160.
Training is tied to specific services
No

Setup and migration

Setup or migration service available
No

Quality assurance and performance testing

Quality assurance and performance testing service
No

Security testing

Security services
No

Ongoing support

Ongoing support service
Yes
Types of service supported
Hosting or software provided by a third-party organisation
How the support service works
DPM Digital Health provide an ongoing support service over an agreed fixed period to maintain regulatory compliance services to sustain an organisations resourcing and deliverables in line with project requirements.

Service scope

Service constraints
There are no constraints to the service other than those that will be conveyed to the client due to unforeseen circumstances such as sickness.

User support

Email or online ticketing support
Email or online ticketing
Support response times
We aim to respond to all questions within a 48 hour period as a maximum.
User can manage status and priority of support tickets
No
Phone support
Yes
Phone support availability
9 to 5 (UK time), 7 days a week
Web chat support
No
Support levels
We provided support services that include onsite, conference call, telephone and email as appropriate to manage any issues encountered. This is over and above our usual terms of agreement with any given client that includes their usual operational support during any working day.
There will always be an allocated resource to respond to any issues given the nature of our business.

Resellers

Supplier type
Not a reseller

Staff security

Staff security clearance
Staff screening not performed
Government security clearance
None

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
Yes
Any other security certifications
Data Security and Protection Toolkit (DSPT)

Social Value

Social Value

Social Value

  • Fighting climate change
  • Covid-19 recovery
  • Wellbeing

Fighting climate change

We promote remote working to reduce the burden on travel therefore reducing carbon footprint, We encourage all consultants to utilise public transport wherever possible when visiting client sites.
We encourage all consultants to utilise digital tools and being cognisant of not printing wherever possible.
All resources are available online, however those that are printed are laminated for reuse wherever possible.

Covid-19 recovery

DPM Digital Health records a degree of caution around the current, prevailing, and uncertain COVID-19 related circumstances and thus changes to UK Government advice and restrictions around working from home may require this to be undertaken remotely.
All consultants will use its own discretion to secure the requirements, using established remote working communication tools [e.g., MS Teams] cognisant of information and cyber security considerations but also in accordance with prevailing UK Government advice and restrictions.
We have adopted a remote working policy that remotes flexible working in support of all consultants taking into account their individual needs.

Wellbeing

We consider our consultants and team members our most important assets who are encouraged to and are supported to apply appropriate work/life balance taking into account individual circumstance which is fully supported by the organisation.

Pricing

Price
£650 to £750 a unit a day
Discount for educational organisations
No

Service documents

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 dean.mawson@dpmdigitalhealth.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.