Software as a Medical Device, AI as a Medical Device and Machine Learning
Ensure complete regulatory compliance in all your artificial intelligence and software-based MedTech devices.
Overcoming regulatory hurdles in high-tech MedTech devices
Trust Apotech for complete compliance
At Apotech, we understand the growing challenges global health systems face due to rising demands and limited capacity.
To tackle these issues head-on, we’ve noticed a shift towards the need for technological solutions, especially in the areas of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD).
SaMD is designed to cover medical software created for diagnostic, monitoring or treatment purposes, excluding hardware components. Whereas AIaMD involves using software that harnesses AI algorithms for clinical decision-making, predictive analytics and data-driven insights.
Through our team’s expertise and experience, we can help MedTech manufacturers within this area reach markets around the globe with complete compliance and expedited entry.
Trusted by top-tier teams worldwide
Our range of SaMD, AI as a Medical Device and Machine Learning Services
At Apotech, we are well-versed in the complexities that introducing cutting-edge MedTech solutions to new markets can bring.
That’s why we’ve designed our wide array of services to offer you strategic insights and hands-on support, ensuring not only regulatory approval but also long-term commercial success.
Why choose Apotech for SaMD, AI as a Medical Device and Machine Learning?
With over fifty per cent of our MedTech portfolio comprising AI or software solutions, we've collaborated with numerous MedTech companies over the past few years, ensuring compliance and implementing quality assurance practices for their products.
Through our specialised methodology, we can now navigate these agile entities through our regulated environment, facilitating compliance, mitigating risks and expediting entry into markets like the EU, USA and UK.
Featured case studies
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…