CANCELLED - MassMEP ISO 13485 Collaborative Sessions
Presented by MassMEP (Manufacturing Extension Partnership)
WHEN
- February 7, 2012 8:00 AM - 11:00 AM
WHERE
- Emerging Enterprise Center at Foley Hoag
- Bay Colony Corporate Center, North Entrance
- 1000 Winter Street - Suite 4000
- Waltham, MA 02451
- Map
DESCRIPTION
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
Registration: contact Kathie Mahoney at the MassMEP at 508-831-7020 or e-mail kathiem@massmep.org