Our industry
expertise.
At DPM Digital Health we have been able to support health organisations and digital health manufacturers with their regulatory compliance journeys. By utilising subject matter expertise within the healthcare sector we are able to give back our own experiences to enhance the knowledge and skill sets of those organisations that are trying to make a difference.
It is our goal to make sure that digital health systems are designed, developed, deployed and implemented in a safe and effective manner allowing the healthcare community to deliver care in a safe and efficient way.
Our pedigree speaks for itself working with the NHS and digital health manufacturers on numerous digital health projects, representing the clinical safety community at conferences and on healthcare forums, publishing documentation in support of the clinical risk management process and having many years experience working in frontline clinical areas.
NHS Safety Standards – DCB0129/DCB0160
DCB0129 Clinical Risk Management – its Application in the Manufacture of Health IT Systems provides a set of requirements suitably structured to promote and ensure the effective application of Clinical Risk Management. It is aimed at those persons within a Manufacturer’s organisation who are responsible for ensuring the safety of Digital Health systems through the application of Clinical Risk Management process and activities.
DCB0160 Clinical Risk Management – its Application in the Deployment and Use of Health IT Systems provides a set of requirements suitably structured to promote and ensure the effective application of Clinical Risk Management. It is aimed at those persons within a Health Organisation who are responsible for ensuring the safety of Digital Health systems through the application of clinical risk management in its deployment, use, maintenance or decommissioning. This standard mirrors DCB0129 in its approach and the majority of its content.
Both standards are mandated under the Health and Social Care Act 2012. Information pertaining to the standards can be found under section 250.
In recent years the growth in the digital health market has been exponential which means there is a potential increase in the amount of clinical safety incidence in the healthcare sector which need to be managed and placated by robust clinical risk management (CRM) process being in place. This can be achieved by producing and maintaining risk management files for the client base that is commensurate to the health IT system and the project it is applied to.
By mobilising a team of SMEs which include Clinical Safety Officers (CSOs), Safety Engineers (SEs) and other professionals within the sector we can provide a service that not only manages all clinical safety activity but also has 25+ years’ experience within the healthcare sector to bring to the table with an extensive network that we can utilise as needed to support the project.
NHS Safety Standards – DCB0129/DCB0160
DCB0129 Clinical Risk Management – its Application in the Manufacture of Health IT Systems provides a set of requirements suitably structured to promote and ensure the effective application of Clinical Risk Management. It is aimed at those persons within a Manufacturer’s organisation who are responsible for ensuring the safety of Digital Health systems through the application of Clinical Risk Management process and activities.
DCB0160 Clinical Risk Management – its Application in the Deployment and Use of Health IT Systems provides a set of requirements suitably structured to promote and ensure the effective application of Clinical Risk Management. It is aimed at those persons within a Health Organisation who are responsible for ensuring the safety of Digital Health systems through the application of clinical risk management in its deployment, use, maintenance or decommissioning. This standard mirrors DCB0129 in its approach and the majority of its content.
Both standards are mandated under the Health and Social Care Act 2012. Information pertaining to the standards can be found under section 250.
In recent years the growth in the digital health market has been exponential which means there is a potential increase in the amount of clinical safety incidence in the healthcare sector which need to be managed and placated by robust clinical risk management (CRM) process being in place. This can be achieved by producing and maintaining risk management files for the client base that is commensurate to the health IT system and the project it is applied to.
By mobilising a team of SMEs which include Clinical Safety Officers (CSOs), Safety Engineers (SEs) and other professionals within the sector we can provide a service that not only manages all clinical safety activity but also has 25+ years’ experience within the healthcare sector to bring to the table with an extensive network that we can utilise as needed to support the project.
Digital Technology Assessment Criteria (DTAC)
The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital health systems they use meet our clinical safety, data protection, technical security, interoperability and usability and accessibility standards. This is achieved by combining regulatory compliance and good, safe practices within the five areas mentioned.
Our team of subject matter experts will work with your organisation to support DTAC readiness utilising your existing resources and compiling the evidence base to completion. DPM Digital Health works in a collaborative approach with best of breed associates to help deliver safe and effective digital health systems to the healthcare sector.
- Clinical Safety
- Data Protection
- Technical Security
- Interoperability
- Usability and Accessibility
Digital Technology Assessment Criteria (DTAC)
The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital health systems they use meet our clinical safety, data protection, technical security, interoperability and usability and accessibility standards. This is achieved by combining regulatory compliance and good, safe practices within the five areas mentioned.
Our team of subject matter experts will work with your organisation to support DTAC readiness utilising your existing resources and compiling the evidence base to completion. DPM Digital Health works in a collaborative approach with best of breed associates to help deliver safe and effective digital health systems to the healthcare sector.
- Clinical Safety
- Data Protection
- Technical Security
- Interoperability
- Usability and Accessibility Accessibility
Clinical Risk Management
Our team have decades of experience in the Digital Health sector including acute and primary health care knowledge, collaboration with and supporting projects for the NHS digital clinical safety team over a number of years, working for digital health manufacturers and their client base which includes both NHS Trusts and independent health organisations.
All team members have undergone the accredited NHS England Clinical Risk Management training in accordance with DCB0129 & DCB0160. This allows them to implement and maintain a Clinical Risk Management System that supports the NHS safety standards in its approach and is fully integrated with the organisations existing processes.
Clinical Risk Management
Our team have decades of experience in the Digital Health sector including acute and primary health care knowledge, collaboration with and supporting projects for the NHS digital clinical safety team over a number of years, working for digital health manufacturers and their client base which includes both NHS Trusts and independent health organisations.
All team members have undergone the accredited NHS England Clinical Risk Management training in accordance with DCB0129 & DCB0160. This allows them to implement and maintain a Clinical Risk Management System that supports the NHS safety standards in its approach and is fully integrated with the organisations existing processes.
Appointed Clinical Safety Resource
Clinical Safety Officer – our dedicated team member will act as your Clinical Safety Officer which means they can start immediately in implementing and managing your Clinical Risk Management System (CRMS) and producing a Clinical Risk Management file which will include all the required safety documentation to meet compliance with the NHS safety standards, DCB0129 & DCB0160 which will include:
- Clinical Risk Management Plan
- Hazard Log
- Clinical Safety Case Reports
- Clinical Safety Management System
- Clinical Safety Incident Log
- Incident Reporting System/Processes
- Clinical Risk Management governance support
- DCB0129/DCB0160 compliance checklist (as appropriate)
Clinical Risk Management resource – Our team members can take the lead and produce the required safety documentation for you. This gives you the flexibility to use your resources effectively during the development and implementation of your Digital Health system.
Alternatively, our team members can work alongside your own team to support and guide them in producing safety documentation and maintaining your Clinical Risk Management System allowing your team to have full control of the process.
Appointed Clinical Safety Resource
Clinical Safety Officer – our dedicated team member will act as your Clinical Safety Officer which means they can start immediately in implementing and managing your Clinical Risk Management System (CRMS) and producing a Clinical Risk Management file which will include all the required safety documentation to meet compliance with the NHS safety standards, DCB0129 & DCB0160 which will include:
- Clinical Risk Management Plan
- Hazard Log
- Clinical Safety Case Reports
- Clinical Safety Management System
- Clinical Safety Incident Log
- Incident Reporting System/Processes
- Clinical Risk Management governance support
- DCB0129/DCB0160 compliance checklist (as appropriate)
Clinical Risk Management resource – Our team members can take the lead and produce the required safety documentation for you. This gives you the flexibility to use your resources effectively during the development and implementation of your Digital Health system.
Alternatively, our team members can work alongside your own team to support and guide them in producing safety documentation and maintaining your Clinical Risk Management System allowing your team to have full control of the process.
Clinical Risk Management Training
We’re thrilled to announce that DPM Digital Health has been awarded Continuing Professional Development (CPD) accreditation by the Faculty of Clinical Informatics and the CPD Certification Service. This prestigious recognition demonstrates our commitment to providing high-quality, informative, and relevant learning experiences to our clients and partners.
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 2 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.
The course is 1.5 days in length covering the following topics:
- NHS safety standards – DCB0129/DCB0160
- Clinical Risk Management process – Risk Analysis, Risk Evaluation & Risk Control
- Hazard identification techniques
- Hazard Workshop planning and management
- Operational Clinical Risk Management activities
- DCB0129 & DCB0160 workshop scenarios (half day session)
- Clinical Risk Management tools and guidance
- Clinical Incident Reporting & Management
Clinical Risk Management Training
We’re thrilled to announce that DPM Digital Health has been awarded Continuing Professional Development (CPD) accreditation by the Faculty of Clinical Informatics and the CPD Certification Service. This prestigious recognition demonstrates our commitment to providing high-quality, informative, and relevant learning experiences to our clients and partners.
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 2 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.
The course is 1.5 days in length covering the following topics:
- NHS safety standards – DCB0129/DCB0160
- Clinical Risk Management process – Risk Analysis, Risk Evaluation & Risk Control
- Hazard identification techniques
- Hazard Workshop planning and management
- Operational Clinical Risk Management activities
- DCB0129 & DCB0160 workshop scenarios (half day session)
- Clinical Risk Management tools and guidance
- Clinical Incident Reporting & Management
UK MDR and EU MDR (UKCA/CE marking)
Digital Health manufacturers will need to demonstrate compliance with the medical device directive and regulations, register their software as a specific class of medical device and completing the required assessment process and documentation to meet the directive requirements and registration process.
Our team members are well rehearsed in this process and have worked alongside the medical device regulations for many years. They will be able to walk you through the process for compliance and give you advice and guidance in completing the required documentation or manage the complete process for you depending on your specific need.
MDR compliance activities include:
- Declaration of conformity
- Technical documentation production and maintenance
- Clinical evaluation plans and reports
- Post Market Surveillance & Vigilance
- CAPA management
- Integration with DCB 0129 NHS safety standard
- Quality Management Systems
- ISO13485 internal audit (NQA certified team members)
- ISO 13485 compliance management (NQA certified team members)
- Responsible person for regulatory compliance
- Regulatory Compliance strategy
- UKCA/CE marking
- Harmonised Standards – ISO 13485, ISO 62304, ISO 14971
UK MDR and EU MDR (UKCA/CE marking)
Digital Health manufacturers will need to demonstrate compliance with the medical device directive and regulations, register their software as a specific class of medical device and completing the required assessment process and documentation to meet the directive requirements and registration process.
Our team members are well rehearsed in this process and have worked alongside the medical device regulations for many years. They will be able to walk you through the process for compliance and give you advice and guidance in completing the required documentation or manage the complete process for you depending on your specific need.
MDR compliance activities include:
- Declaration of conformity
- Technical documentation production and maintenance
- Clinical evaluation plans and reports
- Post Market Surveillance & Vigilance
- CAPA management
- Integration with DCB 0129 NHS safety standard
- Quality Management Systems
- ISO13485 internal audit (NQA certified team members)
- ISO 13485 compliance management (NQA certified team members)
- Responsible person for regulatory compliance
- Regulatory Compliance strategy
- UKCA/CE marking
- Harmonised Standards – ISO 13485, ISO 62304, ISO 14971
ISO 13485 compliance and management
The purpose of ISO 13485 is to provide a series of requirements for a quality management system specifically for an organisation involved in one or more stages of the life-cycle of medical devices and or related services.
To achieve this, the system must not only be implemented but maintained, utilised, monitored and continuously improved. Fully integrating the system with the operation of the business is essential. A QMS that fulfils the requirements of ISO 13485 will also provide support for compliance to elements of the UK MDR & EU MDR when effectively implemented. Patient safety and user risk also play an important role in medical device quality management.
Our team members are experienced in the QMS process and have supported organisations with ISO 13485 development, management, internal and external audits. They will be able to walk you through the process for compliance and give you advice and guidance in completing the required documentation or manage the complete process for you depending on your specific need.
ISO13485 management and compliance activities include:
- ISO 13485 gap analysis – review of existing processes to improve and maintain good practice
- Quality Manual production
- Definition of processes and procedures and their interactions working with your organisations team members
- Working collaboratively to define work instructions and the underlying requirements
- ISO 13485 Internal Audit (NQA certified team members)
- ISO 13485 External Audit preparation and support (NQA certified team members)
- Ongoing maintenance and improvement
- Harmonised Standards – UK MDR, ISO 62304, ISO 14971
ISO 13485 compliance and management
The purpose of ISO 13485 is to provide a series of requirements for a quality management system specifically for an organisation involved in one or more stages of the life-cycle of medical devices and or related services.
To achieve this, the system must not only be implemented but maintained, utilised, monitored and continuously improved. Fully integrating the system with the operation of the business is essential. A QMS that fulfils the requirements of ISO 13485 will also provide support for compliance to elements of the UK MDR & EU MDR when effectively implemented. Patient safety and user risk also play an important role in medical device quality management.
Our team members are experienced in the QMS process and have supported organisations with ISO 13485 development, management, internal and external audits. They will be able to walk you through the process for compliance and give you advice and guidance in completing the required documentation or manage the complete process for you depending on your specific need.
ISO13485 management and compliance activities include:
- ISO 13485 gap analysis – review of existing processes to improve and maintain good practice
- Quality Manual production
- Definition of processes and procedures and their interactions working with your organisations team members
- Working collaboratively to define work instructions and the underlying requirements
- ISO 13485 Internal Audit (NQA certified team members)
- ISO 13485 External Audit (NQA certified team members) preparation and support
- Ongoing maintenance and improvement
- Harmonised Standards – UK MDR, ISO 62304, ISO 14971
Information/Cyber Security
DPM Digital Health works in a collaborative approach with best of breed associates to deliver safe and effective digital health systems to the healthcare sector. We have grown our client base by making sure we utilise the most experienced subject matter expertise (SME) through partnerships within digital health sector.
We have information & cyber security SMEs with 25+ years experience working with digital health manufacturers and health organisations supporting the implementation of their security management systems.
- Data Security & Protection Toolkit (DSPT)
- Data Protection Impact Assessment (DPIA)
- Cyber Essentials/Cyber Essentials Plus
- ISO27001 compliance, internal audit
- ISO27001 external audit support
Information/Cyber Security
DPM Digital Health works in a collaborative approach with best of breed associates to deliver safe and effective digital health systems to the healthcare sector. We have grown our client base by making sure we utilise the most experienced subject matter expertise (SME) through partnerships within digital health sector.
We have information & cyber security SMEs with 25+ years experience working with digital health manufacturers and health organisations supporting the implementation of their security management systems.
- Data Security & Protection Toolkit (DSPT)
- Data Protection Impact Assessment (DPIA)
- Cyber Essentials/Cyber Essentials Plus
- ISO27001 compliance, internal audit
- ISO27001 external audit support
"The support, dedication, and attention to detail that we have received from DPM Digital Health Consulting Ltd has been second to none. It is nice to work with an organisation that truly and deeply cares about clinical and systems safety."
"I would strongly recommend DPM Digital Health Consultancy for their outstanding expertise and guidance, particularly at a time when the safe implementation of digital technology is crucial. We have been really supported in navigating the complexities of integrating technology."
"Dean is genuinely a great person – direct but open, honest, and transparent which translates into how he interacts with others professionally ... seamlessly fielding any queries while sharing relevant resources and materials without question."
Get in touch.
We’d love to hear from you.
Simply fill out the form and we’ll get back to you as soon as we can. Alternatively, give us a call on 07840 049772 or email dean.mawson@dpmdigitalhealth.co.uk
