Following industry standards
The process of caring for a patient has become increasingly complex in the light of evolving standards, delivery models and regulatory landscapes. It's a challenge we are addressing in multiple aspects.
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From data to valuable information
Enabling safe, reliable, effective and prompt care
With market-proven health information exchange experiences, we help you transform data into meaningful information. Medical devices, IT best practices and compliance are delivered according to IHE and other international standards, including relevant EU, UK, NL regulations for digital healthcare solutions. Seamless, secure and reliable connectivity of heterogeneous systems brings new value to data and supports professionals in their decisions for optimal patient care.
For more information, please contact privacy@parsek.com.
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Positive-sum on safety
No shortcuts on user and patient Safety
Together with our solutions, there comes the certainty that EU Medical Device Regulation (MDR) and Medicines and Healthcare products Regulatory Agency (MHRA) requirements about safety and clinical reliability are met. By tight collaboration with a Clinical Safety team, we elaborate on every possible implication on patient and user safety prior to any solution extension.
- Privacy By Design (PbD) framework
- ISO 14971:2019 — Application of risk management to medical devices
- ISO 270X - Information Security Management System
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User centricity
Balancing Security, Privacy, Usability and Business Value
Actively involving business stakeholders, professional users and patients to deliver value and user experience in balance with the security and privacy of data.
- IEC 62366-1 - Application of usability engineering to medical devices
- WCAG 2.1 - Web Content Accessibility Guidelines
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Surprise-free with regulations and guidelines
Flexible in adopting market-specific regulations and health data exchange specifics
- Leveraging know-how in national regulative frameworks and health information exchange specifics on several European markets (the United Kingdom, The Netherlands) to deliver compliant solutions and services to all relevant market requirements.
- Most widespread IHE integration profiles are enabling authentication and authorisation, auditing and data exchange. See our Integration statement for more information.
- ISO 13485:2016 and IEC 62304 certified Quality Management System (QMS) and Systems development life cycle (SDLC).
- Medical Device Directive 100% respected. Vitaly Questionnaires built on top of Vitaly Platform are registered as Medical Device.
- In the transition period for receiving medical device registration under Medical Device Regulation rules.
- Registered as an Economic Operator in the Eudamed databank.
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Continuous improvement
Yearly independently audited Quality Management System
To assess our journey to excellence and discover improvements, we are independently audited for medical device development focused on the application of safety, security, risk and usability controls.
Quality management:
- ISO 9001 – Quality Management Systems
- ISO 13485 - Quality Management Systems – Medical Devices
- IEC 62304 -medical device software – software lifecycle processes
Risk control:
- ISO 14971 - medical devices - application of risk management to medical devices
- ISO/IEC 27001 - information security management
