Upcoming Events

MassMEP ISO 13485 Collaborative Sessions

ISO13485 is being imposed on the medical device supply chain - customers in the medical industry want to be reassured that their business partners will continue to meet their needs for sustainable quality.

The MEP ISO 13485:2003 Collaborative Program allows small to medium-size companies to undertake the ISO13485 certification process with the support from a team of experts at an affordable cost and in a short period of time.

How the Collaboration Works

   •  A unique, workshop-based program that focuses on providing systems, documentation and training in a classroom setting as well as on-site consultation.

   •  Seven off-site, one-day training workshops - one workshop per month

   •  Six to eight on-site, consulting days (based on company size)

   •  A Gap Assessment of each participating company to set the benchmark criteria


Benefits of Becoming ISO 13485 Certified

   •  Emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes

   •  Designed to produce a management system that facilitates compliance to the requirements of customers and global regulators


Benefits of using the Collaborative

   •  Share the cost of training

   •  Learn while developing a compliant quality management system

   •  Benefit from interacting with other participating organizations and sharing best practices

   •  Ensure effectiveness of all processes

   •  One- year membership to Mass Medic


Dates, Locations, and Times

Cost: Free (pre-registration required)

Registration: contact Kathie Mahoney at the MassMEP at 508-831-7020 or e-mail kathiem@massmep.org

MassMEP reserves the right to limit attendance to their public events.