RBridge Lifesciences Pvt Ltd | Regulatory Affairs and Quality compliance Services Provider

ISO 13485 Certification is the world’s most accepted and followed international Quality Management System (QMS) standard by the medical device industry. QMS is designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world. It is a collection of policies, processes, documented procedures, and records to be followed by an organization. 

The most important point about ISO 13485 is that it is often used in a regulatory environment. Medical device manufacturers use it to implement an effective management system to meet regulatory requirements of the most of the countries.

RBridge is specializes in helping organizations become ISO 13485 compliant and achieve ISO 13485 Certification. We do quality consulting for the Medical Devices Industry to offer you expert guidance & know-how, coaching & mentoring, online and onsite training, templates and everything you need to achieve ISO 13485 Certification. We help in creation of the SOPs, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the next phase, we assist to implement the system at shop floor and provide the need-based training to make sure that the system is adequately implemented.