Comprehensive training and full-service consulting solutions empowering organizations to implement a sustainable ISO 13485 Medical Devices QMS

ISO 13485 provides the framework to support your organization to adhere to the increasingly stringent regulatory requirements that impact all aspects of the product development process and life cycle, extending to aspects of service and delivery. Designed to be used by organizations involved in the design, production, installation and servicing of medical devices, ISO 13485 is based on the foundation of the latest quality management system practices, uniquely positioned for the medical devices industry sector. 

Our Areas of Expertise

Medical Devices Quality Management Consulting Services

Our mission it to develop a deep understanding of your organization's internal processes and business needs, and adapt the scope of our consulting efforts to meet your desired business outcomes. The first step is connecting with a Plexus representative and we'll carefully assess your unique needs.

ISO 13485 Medical Devices Quality
Management System Implementation

Management System

Outsourced Internal Audits
(1st Party) for ISO 13485