Tom Middleton

Solutions architect, biomedical auditor

Tom Middleton is a solutions architect for Sparta Systems Inc. Formerly an ASQ/RAB-accredited lead auditor for Underwriter’s Laboratories and Bausch + Lomb’s surgical division, Middleton has conducted nearly 1,000 registration, surveillance, internal, and supplier audits. Currently he is an ASQ-certified biomedical auditor. Middleton’s experience includes auditing of compliance to good manufacturing practices, international standards, and regulations for automotive, life science, medical device, and the consumer product vertical sectors, including: ISO 9001, ISO 13485, ISO 17025, ISO 14000, FDA 21 CFR 820, Japanese Pharmaceutical Affairs Law (JPAL), Canadian Medical Devices Conformity Assessment System (CMDCAS), EU Medical Device Directive (MDD), and the Brazilian ANVISA standards.

 

Wed, 03/08/2017 - 12:01
Effective Supplier Integration for FDA- and ISO-Compliant Quality SystemsIt’s all about transparency, accountability, and efficiency
Thu, 05/17/2018 - 12:02
Markets and manufacturing practices continue to evolve, and companies now outsource to an increasing number of global manufacturing and supply partners. As companies have pursued this broadened supply chain strategy, the ability to manage both…
The Most Important Question to Ask About Your Audit ProgramEffectively leveraged, audit information can transform organizations
Wed, 03/08/2017 - 12:01
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good…