Security and Information Governance
Bleepa is a secure, encrypted, zero-footprint application, meaning that no patient data is stored locally on any device. It is manufactured using processes that adhere to the ISO 13485 quality standard, ISO 27001 information security and Cyber Essentials Plus security standards and is the only communications platform on the NHSX clinical communications framework to be certified as a CE marked medical device for undertaking medical image review.
Background
Bleepa has evolved from PACS and has been developed by the leading medical device manufacturer Feedback Medical Limited, which has a long-standing history with clinical medical imaging.
Bleepa is powered on a fast, scalable and secure cloud infrastructure, it is compatible with existing PACS frameworks and is easy to install and implement. It is a regulated, safe and proven communications imaging tool.
It can be used for multi-disciplinary team meetings and offsite access to imaging meaning that you don’t need additional web PACS licences from your current PACS vendor, saving you money and allowing flexible working for your clinicians.
ISO Certificates
At Bleepa we ensure our products and processes are of a high standard and comply with the laws and regulations of the medical device industry.
We produce and manufacture our products within an ISO 13485 Quality Management System (QMS). Our QMS incorporates the EU requirements for medical device manufacture as well as the needs of U.S Medical Device regulation (21 CFR 820). We have the capability to produce medical image analysis software products that satisfy the needs of 21 CFR 11 and HIPAA.
In we also have a certification for ISO 27001 for data management security. ISO 27001 is the international standard that outlines the requirement for an information security management system (ISMS). Its best-practice approach helps organisations manage their information security. It does this by addressing people and processes, as well as technology.
Our CE Mark
Our CE mark demonstrates the stringent criteria we have met as to manufacture our device.
All clinical communication platforms that display digital images of patients for the purpose of diagnosis are classed as medical devices under the Medical Device Directive (MDD) guidelines and require a CE mark. Bleepa is the only communication platform to address the UK market that has met MDD certification requirements.
Using non-CE marked products inappropriately may put individual clinicians and trusts at risk of civil claims for damages arising from misuse of that product. Therefore, the Medicines & Healthcare products Regulatory Agency (MHRA) advise that all providers only use appropriately CE marked devices.
Cyber Essentials Plus Certificate
The Cyber Essentials Plus audit is a government backed scheme that protects organisations from a range of the most common cyber-attacks. Our Cyber Essentials Plus certificate demonstrates our commitment to cyber security.
