Our development processes adhere to ISO 27001 standards for information security management systems, ensuring comprehensive protection of sensitive healthcare data.

Key Implementation Areas:

• Information security policies and procedures

• Risk assessment and treatment

• Security controls implementation

• Monitoring and continuous improvement

• Incident management protocols

For medical device software, we implement ISO 13485 quality management systems to ensure consistent development of safe and effective software.

Key Implementation Areas:

• Quality management system documentation

• Design and development controls

• Verification and validation processes

• Risk management throughout development

• Traceability of requirements and changes

We implement comprehensive measures to ensure compliance with the Health Insurance Portability and Accountability Act for U.S.-focused healthcare applications.

Key Implementation Areas:

• Privacy Rule implementation

• Security Rule technical safeguards

• Breach notification procedures

• Business Associate Agreement compliance

• Administrative and physical safeguards

We build healthcare applications with privacy by design principles that meet the requirements of the General Data Protection Regulation for European data subjects.

Key Implementation Areas:

• Privacy by design and default

• Data subject rights implementation

• Consent management mechanisms

• Data protection impact assessments

• Cross-border data transfer controls

For medical software and applications that qualify as medical devices, we implement development processes that meet FDA requirements and guidelines.

Key Implementation Areas:

• Quality System Regulation (QSR) compliance

• Software as a Medical Device (SaMD) classification

• Design control documentation

• Verification and validation planning

• 510(k) or De Novo submission support

For healthcare applications that process payment information, we implement Payment Card Industry Data Security Standard compliant processes to protect financial data.

Key Implementation Areas:

• Secure network architecture

• Cardholder data protection measures

• Vulnerability management program

• Strong access control measures

• Regular security monitoring and testing

We begin by analyzing the specific regulatory requirements that apply to your healthcare application based on its functionality, target market, and data processing activities.

• Regulatory scope determination

• Compliance requirements mapping

• Gap analysis against current state

• Compliance architecture planning

We conduct comprehensive risk assessments to identify potential threats to patient data security and privacy, and develop mitigation strategies.

• Threat modeling and risk identification

• Impact and likelihood assessment

• Risk prioritization

• Control selection and implementation planning

We integrate compliance requirements into the design phase, ensuring that privacy, security, and regulatory considerations are built into the application architecture.

• Privacy by design implementation

• Security architecture development

• Technical control specification

• Design review and validation

During the development phase, we implement secure coding practices and regular security testing to identify and remediate vulnerabilities early.

• Secure coding standards implementation

• Regular code security reviews

• Dependency vulnerability scanning

• Static and dynamic application security testing

We conduct comprehensive testing and validation to ensure that all implemented controls effectively meet regulatory requirements and security standards.

• Security control testing

• Compliance requirement validation

• Penetration testing

• Documentation review and verification

We prepare comprehensive documentation to demonstrate compliance with regulatory requirements, providing evidence of implemented controls and processes.

• Control implementation documentation

• Risk assessment reports

• Test results and validation evidence

• Compliance attestation preparation