Past successes
Second Quarter 2006
FDA Registration
Company Profile
MTG, recently purchased by Accellent,
Inc., a manufacturer of surgical instrumentation and implants,
employing (85) people, requested TMEP to train their lead auditors
on the ISO standard ISO 13485:2003. After the training was complete
TMEP provided mentoring/counseling on internal audits (both system
and process audits), reviewed audit findings and write-ups, and
mentored auditors as needed.
Situation
MTG received correspondence from one
of their major customers that they have to be FDA registered to
continue to supply this customer parts. This customer provided
MTG (Accellent) over ($10) million in sales for the previous year
and projection were for a substantial increase for the current
year. MTG (Accellent) was aware of this requirement and had contacted
TMEP to start the process of pursuing their FDA registration.
Solution
MTG (Accellent) was striving for their
FDA registration and after the initial FDA registration visit TMEP
provided assistance with a written response to FDA along with guidance
in correcting deficiencies. With TMEP MTG (Accellent) was successful
in obtaining their FDA registration.
Results
After MTG (Accellent) received their
FDA registration this allowed them to pursue more of the medical
implant market. With three of the major implant manufacturers in
the Memphis area MTG (Accellent) has been able to increase sales
to these manufacturers by over $4 million.
Visit the Accellent site
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