ISO 13485 Training Project Seminars – UMass ATMC

When: « Back to Calendar February 2, 2012 @ 8:00 am - 11:00 am
Where: UMass ATMC
151 Martine St
Fall River,MA 02723
USA
Categories: Other Events of Interest

 Jointly sponsored by MassMEDIC and the Massachusetts Manufacturing Extension Partnership (MassMEP).

 ISO 13485 represents a comprehensive management system for the design and manufacture of medical devices and is often viewed as the first step in achieving compliance with European Union medical device regulatory requirements. As many more OEMs look to the European market as a preferred region for product launch, suppliers must consider this quality standard as essential to sustaining supply connections to the medical device market.

 MassMEDIC and MassMEP are partnering to form an educational collaborative that will bring low-cost ISO 13485 training to the region’s medtech community. To learn more about how your company can participate in this training collaborative, I invite you to attend any one of the following informational sessions, scheduled as follows:

Training sessions will commence in the first quarter of the 2012 and, meeting once a month for a day-long session over a six month period. The training will include monthly on-site visits by ISO trainers as well as hands-on preparation and assistance in submitting your company’s ISO 13485 certification application. A flyer with additional information on the collaborative program is included.

 If your company is ISO 9001 registered but not ISO 13485, there are benefits to obtaining both certifications.  ISO  9001 focuses on business aspects not found in 13485 thus providing your company with a stronger business management application.

 Please feel free to contact me directly with any questions about this important training initiative – sommer@massmedic.com.

 To register for one of these events, please contact Kathie Mahoney at 508-831-7020 or kathiem@massmep.org. There is no fee to attend, however preregistration is required. 

About MassMEP ISO13485 Collaborative 

Are your customers asking that you become ISO13485 registered?
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 ISO13485:2003 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  

 For more information about the Collaborative, contact: Mike Prior, michaelp@massmep.org