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Privacy, Security & Quality
Security
Luscii uses an information security management system (ISMS), which is a set of processes for ensuring that information is safeguarded against internal and external security threats. Luscii’s ISMS is ISO 27001:2017 certified.
Luscii is certified for the Cyber Essentials and completes the Data Security Protection Toolkit (DSPT) as well as the Digital Technology Assessment Criteria (DTAC) assessment annually.
Privacy
Luscii assures compliance with the GDPR with regards to data processing, as a Data Controller, as well as a Data Processor on behalf of her customers. Within Luscii, we adhere to the principles of personal data processing according to article 5 of the GDPR:
- Lawfulness, fairness and transparency
- Purpose limitation
- Data minimisation
- Accuracy
- Storage limitation
- Integrity and confidentiality (security)
- Accountability
More details can be found here.
Quality management
Luscii has set in place a Quality Management System ('QMS') for the development, maintenance and post market surveillance of its medical device software, Luscii vitals. Luscii vitals is a CE-marked medical device risk class IIa under the Medical Devices Directive (MDD, 93/42/EEC), transitioning to the Medical Devices Regulation (MDR, EU 2017/745).
The QMS contains all processes to ensure that Luscii vitals is produced as a high quality medical device that consistently meet customer and applicable regulatory requirements. The QMS is certified according to the norms of ISO 13485:2016.
Our product architecture and more details about our quality management system can be found here.
Privacy build in
Privacy is a fundamental human right, especially when dealing with healthcare data. We have made it our top priority to securely handle your patients' data whereas you remain the owner of it. Our safety, quality and privacy are audited externally and certified on the highest levels. Our many awards are living proof of this.