Medical device software

 Medical device software plays a critical role in delivering safe, effective, and compliant healthcare solutions. Our expertise helps manufacturers and healthcare providers design, develop, and maintain software that meets stringent regulatory standards while driving innovation and improving patient outcomes. From early concept to post-market support, we deliver solutions that ensure reliability, security, and scalability—empowering you to stay ahead in a rapidly evolving industry. 

 Quality, regulatory, and clinical research expertise

 We offer end-to-end expertise to help you build and maintain medical device software that meets the highest standards of quality and compliance. Our services include: 

• Regulatory strategy and compliance, including medical device software qualification, classification and validation.
• Technical documentation
• Cybersecurity
• Risk management
• Market registrations and post market surveillance
• Clinical evaluation
• Clinical investigations
• Quality Management System (QMS) services
• Auditing services
• Outsourcing of Quality Managers and PRRCs to strengthen your team