Yes, all Blueberry Diagnostics’ checkups are already validated and registered in Europe as Class I, Rule 12, according to Annex VII of Medical Device Directive 93/42/EEC. Besides, all Blueberry Diagnostics’ checkups already have Health Canada waiver.
Category: <span>2 - Regulatory and certifications</span>
All Blueberry Diagnostics’ checkups comply next Harmonized Standards: EN 62304:2007; CORR:2009. Medical device software – Software life-cycle processes; EN 62366:2009. Medical devices – Part 1: Application of usability engineering to medical devices; EN 1041:2009. Information supplied by the manufacturer of medical devices; and EN 980:2008. Symbols for use in the labelling of medical devices.
All Blueberry Diagnostics’ checkups are based on next medical guidelines: American Academy of Physician Assistants (AAPA); American Association of Clinical Endocrinologists (AACE); American Association of Endocrine Surgeons (AAES); American College of Cardiology (ACC); American College of Physicians (ACP); American College of Preventive Medicine (ACPM); American College of Rheumatology (ACR); American Geriatrics Society (AGS); American Heart...
Besides the Medical Board of the company, integrated by only MD and PhD members, we also have developed several trials with hundreds of patients to check all Blueberry Diagnostics’ checkups outcomes.