Clinical safety

Ensuring the safety of patientMpower products and services

patientMpower believes in empowering better patient outcomes for those living with chronic disease through digital healthcare. It’s our responsibility to ensure that our products and services are safe and reliable for patients to use, and we’ve established clinical safety and risk management processes across all products and services. We undertake rigorous quality testing, usability testing and clinical assurance to ensure clinical safety is met.

Our clinical safety processes

Our clinical safety team regularly reviews and assesses our products to ensure their continued safety and effectiveness. As part of this process we maintain a clinical risk management plan, a hazard log, and a clinical safety case report, as per recognised NHS Digital safety standards.
External usability testing and clinical assurance is an important part of our clinical safety processes, and we ensure that any new feature we develop has been approved by clinical experts. We continuously strive for people’s feedback and suggestions on our services, and welcome positive feedback and any improvements we can make.

Clinical safety case report

We hope to bring transparency to our work and hope to improve patient safety. To request access to our clinical safety case report please contact support@patientmpower.com.

Our clinical safety team

patientMpower’s clinical safety team review the product and processes every fortnight. Our team is overseen by our Clinical Safety Officer who ensures the quality of our safety and risk assessment process.

Members of the team include:

  • Dr. Shailesh Suri (Clinical Safety Officer)
  • Dr. Colin Edwards (Chief Scientific Officer)
  • Kevin Doyle (CTO)
  • Edel Lynch (Head of Product)
  • Rebecca Borton (Customer Success Manager)
  • Jordan Thompson (Product Manager)

Regulation

We’ve implemented our clinical safety processes as per the NHS Digital safety standards. The NHS Digital requires that organisations who manufacture health products and services undertake a clinical risk assessment and provide evidence that measures have been put in place to mitigate risk. DCB 0129 is the UK’s mandatory safety standard for manufacturers of health IT systems and apps, which patientMpower complies to. patientMpower is also regulated in the EEA and is CE-marked under the European Union’s medical device regulatory framework and UKCA marked in the UK.