Salyx is committed to ensuring the highest standards of data security, privacy, and software compliance in its medical applications.

 To evaluate and ensure and ensure compliance with software and cybersecurity regulations for medical applications in the USA and Canada, with a focus on protecting protocols, and following relevant regulations, such as HIPAA, PIPEDA, and FDA guidelines. 

The goal is to identify potential vulnerabilities, ensure the software meets the regulatory requirements in both countries, and provide information to enhance data security, privacy, and overall patient data protection.

• Regulatory Compliance and Assessment Report:

Detailed report of medical software’s compliance with regulations and medical electrical safety

• Security Vulnerabilities and Risks Assessment:

Analysis of the software’s security posture, highlighting potential security risks, and providing recommendations to avoid them.

• Data Privacy and Protection Regulations
• Software Validation and Compliance Checklist  

A checklist or framework that outlines the key compliance requirements for medical software under the USA and Canadian Regulations.

• Risk Mitigation and Security Improvement Plan

Recommendations to address identified vulnerabilities, improve cybersecurity measures, and enhance software security practices. This plan will include actionable steps to align with best practices and ensure patient data protection

• Understanding of Device firmware and Battery Safety regulations.

-Cloud infrastructure: standards regulations, guidelines, and certifications for APIs, Web applications, and Database

-Firmware: Standards, regulations, and certifications related to UL, Bluetooth, error handling, and wireless communications 

-Mobile applications standards, regulations, guidelines, and certifications for mobile app development.