Our Culture of Quality
Medical Device Directive Compliant
Pacmed Critical is a CE Certified product. This means that the software meets the requirements of the Medical Device Directive and the applicable requirements of the Medical Device Regulation.
The software is developed through standard processes that are documented in a quality management system that meets the ISO 13485 standard. These processes describe how both the developed decision-support software and the corresponding provided information meet standards for safety, performance and validation through clinical evaluation.
Our Commitment to Privacy
All processing of (sensitive) personal data by Pacmed complies with the relevant laws and regulations, such as the GDPR (General Data Protection Regulation). The data is only hosted to the relevant standards and certificates for information security in healthcare.
Internally, Pacmed follows an information security policy which ensures that only authorized staff has access to certain data. With this policy we also guarantee the protection of the data against accidental or unlawful destruction, alteration, storage, processing, access or disclosure. To be compliant with the personal data policy of the healthcare institutions that we work with, we use the BOZ (Brancheorganisaties zorg) model and follow the NCSC (National Cyber Security Centre) guidelines .
Pacmed employees with access to personal data are subject to a signed code of conduct, which also serves as a confidentiality statement and statement of knowledge and understanding of security measures.