Our Quality Policy

Purpose

Our goal at MyPatientSpace (MPS) is to continuously meet and surpass our customers’ requirements by providing quality, innovative, and effective healthcare software products and services that we can be proud of. An integral part of this commitment is upheld through our steadfast adherence to stringent quality control measures in all our operations, including regular security scans and penetration tests to ensure the utmost safety.

Scope

The Quality Policy applies to all individuals, sites, associated organisations, products, procedures, and record-keeping related to MPS, encompassing our ISO 13485:2016 certified Quality Management System (QMS) which stands as a testament to our high standard of quality control in operations.

Policy

MPS is driven by a passion and commitment to delivering secure, effective healthcare software products that meet our customers’ needs, underpinned by our QMS that guarantees the highest possible levels of performance, design, reliability, and quality.

We seek to offer a superior healthcare and medical user experience while continuously elevating our standards through a culture of personal and business accountability. This is achieved by:

  • Setting and complying with quality objectives, substantiated by our ISO 13485:2016 certified QMS, and promoting the requirement for quality throughout the organisation;
  • Continually enhancing the Quality Management System and gauging its effectiveness through active engagement with staff, customers, suppliers, and stakeholders;
  • Validating our security posture by performing regular security scans and penetration tests to preemptively address vulnerabilities;
  • myPatientSpace is CE-marked Class IIa medical device under the Medical Devices Directive (MDD), transitioning to the Medical Devices Regulation (MDR)
  • Adhering to approved business processes and procedures:
    • Meeting, and aiming to exceed, international regulatory requirements and guidelines;
    • Advancing technical delivery capabilities and the scientific understanding of medical/healthcare conditions, bolstered by robust data analysis and real-world evidence, to support improved outcomes for patients;
    • Ensuring that each employee, through proper training and instruction, fully comprehends their role and its direct bearing on the ultimate product quality.

Responsibilities

Management shall ensure that the Quality Policy, grounded on our ISO 13485:2016 certified QMS, aligns perfectly with the aims and aspirations of the organisation, fostering understanding, implementation, and maintenance at all organisational levels.