Understanding ISO 13485:2016

ISO 13485 was revised in 2016 with several new requirements and a stronger emphasis on risk and planning. In fact, the older 2003 version did not define the term “risk” under Terms and Definition (Clause 3). A considerable amount of detail is now provided to clarify the concept of risk, which pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements within the scope of the revised standard.

Regulatory ComplianceNaveen AgarwalAugust 20, 2019quality system regulation, quality management system, ISO 13485:2016, exclusion, non-applicabilityComment

FDA Recognizes It's Time for QSR 2.0

FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

Regulatory ComplianceNaveen AgarwalJune 20, 2019risk management, FDA regulation, safety, medical safety, patient safety, quality system regulation, qsrComment