Medical device software

 Medical device software, including Software as a Medical Device (SaMD), plays a critical role in delivering safe, effective, and compliant healthcare solutions. While manufacturers drive innovation and improve patient outcomes with software, our expertise supports the product design, development and maintenance to meet stringent regulatory standards. From early concept to post-market support, we support you to 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, including medical device software qualification, classification and validation.
• Technical documentation
• Cybersecurity
• Risk management
• Market registrations
• Post market surveillance
• Clinical evaluation and clinical investigations
• Quality Management System (QMS) services and electronic QMS (eQMS) solutions
• Building medical device development environments to support product development and documentation of your medical device or SaMD
• Auditing services
• Experienced Quality Managers and PRRCs for hire to strengthen your team