Compliance and Certifications

Pacmed is dedicated to delivering high-quality, secure, and reliable software solutions. With a focus on compliance, our certifications demonstrate a commitment to meeting the highest safety, security, and regulatory standards.

Medical Device Regulation

Pacmed Critical is a MDR Certified product. This means that the software meets the requirements of the Medical Device Regulation (EU) 2017/745.

To ensure a high level of safety and performance, the software developed by Pacmed meets the general safety and performance requirements laid down in the MDR. In addition, Pacmed ensures that the software life cycle processes are in line with key standards (EN 62304:2006+A1:2015, EN 82304-1:2017, EN 62366-1:2015+A1:2020, ISO 14971:2019+A11:2021).

Pacmed holds ISO 13485 certification, reflecting the company's robust quality management system for medical devices. This certification ensures that processes are in place to consistently produce safe and effective products that comply with international regulatory standards.

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ISO 27001 certified

With ISO 27001 certification, Pacmed ensures that its information security management system meets the highest standards for protecting sensitive information, including patient data. This certification underscores a strong commitment to maintaining data confidentiality, integrity, and availability.

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GDPR compliant

Pacmed fully complies with the General Data Protection Regulation (GDPR), ensuring that all personal data is handled in accordance with EU laws. Although there is no formal certification for GDPR, privacy and security have been embedded into the software’s design and our governance processes, guaranteeing data is processed responsibly and securely

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