Validation of Medical Devices involving Mobile Applications, Software-based, AI/ML-based devices is critical to gaining regulatory approval and marketing. Regulatory constraints are wide-reaching and deep knowledge and up to date awareness of Quality System Regulations (QSR), CSA/CSV process, and cybersecurity regulations are needed to ensure compliant medical devices. Zifo has extensive experience in this domain and experience with SaMD development and validation approaches.
Our Capabilities
Our expertise spans the whole spectrum of scientific process applications, and we’re able
to draw on a huge marketplace of partnerships with science technology providers, so
whatever is needed to fix your current set-up. we’ll determine the best way forward.
Our People
Our people are our business and we invest and support their development and curiosity. We actively promote science in our daily work and over 90% of people in Zifo have a scientific background – meaning we speak & understand the language of science
Glocal
We have a GLOCAL (global & local) presence – meaning we engage with you in your language and time zone but leverage a global delivery support model to remain cost-effective, scalable and very reactive
Focus
We focus on science and scientific process applications and informatics. This means we can provide expertise and domain knowledge without compromising quality, technical and service delivery excellence
Partnerships
Our huge marketplace of partnerships with science technology and informatics platform providers means you can rely on Zifo to be agnostic and advise on strategy, plan & deliver projects, and validate and maintain your scientific informatics environments
