Is it true that the FDA is considering regulating scope and instrument repair?

Yes. In the past several months, there have been discussions of the FDA possibly regulating the independent service organization in the instrument and scope repair market.

TOTAL SCOPE is ready!

Total Scope, Inc. has been an ISO certified company for 17 years. We were the first registered company in our industry to be awarded the ISO 13485 certificate.

Total Scope’s earliest quality meetings were shaped by a thorough understanding of the FDA’s Quality System Regulations. It was a milestone event for our company when we harmonized the FDA Quality System Regulation and the ISO 13485 independent audit system together at Total Scope, Inc.

Total Scope, Inc. has been complying with the FDA’s Quality System Regulations for the past 17 years through our ISO 13485 certification. Our procedures, such as, training, calibration, internal audits, recalls, non-conformance review, process evaluation, warranties, complaint handling and data analysis, have been implemented and maintained.

Total Scope, Inc. made the choice 17 years ago to become an ISO certified company given that we repair products used on patients every day.