Mentor360 Ltd regularly audits and monitors the regulatory standards of which they must comply with. In the technology’s current state the Mentor360 app does meet the criteria to qualify as a medical device under The Medical Device Directives and therefore does not need a CE or UK CA mark. We understand that with changes to the apps functionality and use cases this could change and take responsibility to regularly assess future developments against the Medical Device qualifying criteria.
Dr Alexandra Lagaisse BSc (hon psychology), MSd Holistic Science and Doctorate Clinical Psychology has been involved in the development of Mentor360.
All Mentor360 content (formulas and blogs) are written and checked by experts in performance psychology, holistic mindfulness, well-being and mental health. Sense checking of content is done by professionals who have evidenced suitable qualifications and experience within their field such as Dr Alexandra Lagaisse BSc as well as the Clinical Safety Team composed of Karen Whitton and Lyndon Johnson both registered nurses.
8foldGovernance positively evaluated or validated by a relevant healthcare professional.
Current deployments of the Mentor360 app include:
- Users on the Android and IOS stores.
- NCL NHS within primary care.
- Within all deployments reporting procedures are in place which allow for bug fixes and app updates.
A structured and rigorous clinical safety assessment led by a DCB 0129/0160 trained clinical safety officer and production of clinical risk management documentation compliant to DCB0129 as per section 250 of the Health and Social Care Act 2012 has been completed. Mentor360 supported the work with a senior company, clinical and development engagement and provided evidence that demonstrates that the Mentor360 software application has a safety profile that is deemed tolerable, with all hazards mitigated ‘As Low As Reasonably Possible.’ There are no known hazards that have been identified as being a significant or high clinical safety risk following implementation of mitigations described in the Hazard Log.
All software changes and new content go through a Clinical Risk Management Process, within this evaluation process any changes made to the app must be approved by Mentor360’s named Clinical Safety Officer: Karen Whitton from 8foldGovernance (www.8foldgovernance.com) and assessed by the rest of the clinical safety team for accuracy.
Risk Management Process:
External Health Care Professional Valuation
MENTOR360 is one of the best well-being apps I’ve seen in the app marketplace. It is extremely broad, covering many facets of well-being, including emotional well-being, healthy mind, life balance, physical fitness, diet, and performance. The app provides a ‘hub’ comprising of an extensive amount of high quality, expert, information and resources, covering many different areas of well-being. Resources include videos, podcasts, blogs and workouts. Further to the ‘hub’, the app also allows you to track your well-being, highlighting which area of life you need to focus on more. The other main feature is the ‘formulas’ which is very clever and unique function of the app, giving the user simple daily recipes for promoting well-being in different areas of life. This combination of features, together with the ‘non-clinical’ and holistic ethos of the app gives the user a sense of empowerment and positivity, promoting mental ‘fitness’ and fulfilment in life. I would thoroughly recommend this app.Dr Katie Morris. Clinical Psychologist & Managing Director of The Purple House Clinic