Software as a Medical Device: Partnership with Conlis Global

Software as a Medical Device (SaMD) is a type of software intended for medical use that operates independently from a hardware medical device. Since being defined by the International Medical Device Forum in 2013, the SaMD’s market size continues to grow, reaching 1.8 Billion this year, and is expected to increase to 6 Billion in the next ten years. 

The Promise and Challenges of SaMD

SaMD holds great promise for transforming healthcare by offering innovative solutions for diagnosis, treatment, and patient management. However, it also presents significant challenges that developers must navigate to ensure safety, effectiveness, and compliance. 

Key Challenges in SaMD Development

By addressing regulatory complexities, enhancing cybersecurity, demonstrating clinical effectiveness, optimizing usability, and keeping pace with technological advancements, the SaMD industry can overcome these challenges and unlock its full potential. The FDA’s and European Parliament’s guidance and global collaboration efforts provide a valuable framework to support this evolving field, ultimately benefiting patients and healthcare providers worldwide.

Strategic Partnership Announcement

Having said that, we are excited to announce a strategic partnership between needCode and Conlis Global Inc. The Canadian biotech company, a leader in bridging the gap between research and development and go-to-market for healthcare products, brings extensive expertise in clinical development and regulatory compliance. needCode contributes vast experience in developing dedicated IoT solutions and embedded software, with skilled R&D and cybersecurity experts on board. 

Combining Expertise for SaMD Innovation

Together with Conlis Global Inc., we bring unique skill sets, working collaboratively to explore the potential of SaMDs in healthcare while ensuring compliance with regulatory standards. We are well-positioned to navigate the complexities of Software as a Medical Device development, ensuring that these cutting-edge tools can effectively and safely revolutionize healthcare delivery.