Quality Management System Services for Medical Software

What we do:

We help our clients implement lean and optimised Quality Management System (QMS) and Software Development Life Cycle (SDLC) procedures tailored for medical software development. Our approach integrates Agile methodology while ensuring compliance with EU MDR, FDA 21 CFR 820, and key international standards, including ISO 13485, ISO 14971, IEC 62304, IEC 82304, ISO 15223-1, ISO 20417, and EN 62366-1.

Additionally, we assist clients in selecting and implementing the right software tools to support efficient design and development processes, ensuring consistency, traceability, and regulatory compliance.

Customer benefits:

With our help, clients reduce QMS implementation time, accelerate product market entry, and maintain a high-quality product while ensuring ongoing compliance.