Going Through Changes

摘要

When working in a highly-regulated environment such as the medical technology (med-tech) industry, there is one basic concept all quality and regulatory professionals can take to the proverbial bank: regulations will change. For med-tech professionals, however, the current environment is considerably more volatile than at any other point in recent history. ISO 13485:2016 has been released and implemented, the medical device single audit program is an ongoing challenge, the medical device directives in the European Union are slowly moving toward obsolescence as the medical device regulation is taking hold, and now, ISO/IEC 17025 is migrating to the 2017 version.