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
Explore opportunities for auditors and QMS implementation team members to gain clause-by-clause insights into the ISO 13485:2016 standard.
Leverage the AIAG Core Tools (APQP, PPAP, FMEA, MSA, and SPC) to mitigate risk and consistently manage key processes. Services also available for the new AIAG & VDA FMEA Handbook.
Industry-recognized training on 8-D and Poka Yoke to diagnose and implement appropriate corrective action.
Reduce your organization's global footprint and achieve sustainability by effectively implementing an ISO 14001:2015 - Environmental Management System.
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.