Group performing research and development in a lab environment

The medical device industry is constantly evolving, and with it, the need for effective risk management strategies. At Innovenn, we understand the importance of identifying and mitigating potential risks associated with a medical device, combination drug/device or software as a medical device (SaMD) product. Our team of experts have years of experience in providing risk management consulting services for clients in these industries. We work closely with our clients to develop and implement strategies that reduce the likelihood of product failure and support compliance with regulatory standards.

Risk Management in Product Development

Innovenn can provide guidance and support throughout the complete risk management process in conformance with ISO 14971, from developing a risk management plan to conducting risk management activities. These include: