TDC Medical is pleased to announce the recent addition of Mark Denning as
Director of Quality. Mark primarily will be responsible for managing
Quality Systems for TDC East. He will support clients’ needs in all geographies
and assist in maintaining TDC's internal Quality Systems at the highest level.
Mark joins TDC Medical from Accellent, where he was Director of
Quality Management for 11 locations. Mark has 24 years of varied experience
in the medical device and pharmaceutical industries. In addition to Accellent,
he has worked at companies such as Karl Storz and Nypro. As well as his quality
and regulatory experience, Mark has worked in operations, factory automation
and various aspects of electrical engineering. Mark holds Regulatory Affairs
Certification for US regulations (RAC, US) awarded by the Regulatory Affairs
Professionals Society. The addition of Mark to TDC will allow the company
to further expand its support of clients in Quality Systems processes and procedures.
TDC Medical's Quality Systems Services:
- Customize quality systems to meet specific company needs
& business objectives
- Audit suppliers to ISO 13485:2003 and QSR
- Conduct internal audits
- Develop procedures and processes for project support
- Regulatory submission support, including drafting of submissions
- Oversight and ongoing support of contract sterilization vendors
- Biocompatibility and sterility testing
- Clean room and environmental monitoring
- Document control through the Document Change Order process
- Completed documentation packages:
-
Design History Files
-
Device Master Records
About TDC Medical, Inc.
TDC Medical provides design, development and manufacturing services for
the creation and production of innovative, disposable, therapeutic medical devices. With facilities in both Marlborough, MA and Sunnyvale, CA, TDC can help transition products from the earliest stages of concept design through the entire process to packaged, sterile, clinical devices. TDC's skilled staff has extensive experience in all phases of the product development and manufacturing processes. TDC provides the full spectrum of services to its clients including: concept creation, delivery of working prototypes for evaluation, refinement of design, generation of necessary quality and regulatory documentation, and assembly, packaging, and sterilization.
TDC is happy to work with companies on any or all phases of the process and
on projects small or large. TDC Medical is ready to assist with any process or
phase of product development challenge - from Concept creation to delivery of
Clinical product. For more information go to
www.tdcmedical.com or contact:
Al Hershey For our FULL capabilities
917-566-9224 cell Download our NEW eBrochure
ahershey@tdcmedical.com
www.tdcmedical.com/pdfs/e-brochure.pdf
