Whether you are an established health software publisher or a fast-growing startup, our expertise adapts to your needs.
We support you while considering your goals, strategy, team dynamics, and budget.
Conducting assessments, analyzing impacts, preparing quality & safety documentation, and leading strategic meetings to ensure regulatory compliance
Defining regulatory requirements, developing action plans and quality procedures, and creating a certification roadmap
Project monitoring, coordinating actions between teams, and providing continuous regulatory assistance
Training teams on regulatory requirements, supporting change management, and preparing employees for audits
Hosting regular meetings, liaising with institutions, and organizing workshops on targeted topics
With over 20 years of experience in software development, AILANE is a key player in assisting medical software publishers with their regulatory processes.
Our 15+ years of expertise in health regulations and our deep understanding of medical software publishing, gained through over a decade of project management, make us a trusted partner for ensuring your product’s compliance.
We combine a dual technical-functional skillset, stemming from two decades of software development practice, with a solid understanding of your regulatory challenges. This allows us to deliver pragmatic, effective, and tailored solutions.
