New ISO 14155 Standard Focuses on Medical Device Safety

A revised ISO standard designed to help medical device companies conducting clinical trials keep a handle on product safety and performance, as well as define good clinical practice, was introduced this past spring, and its adoption has been spreading through the medical device industry.  ISO 14155:2011 represents an update of the original ISO standard – aimed at normalizing clinical trial practices – that was first published in 2003.  Specifically, the 2011 version of the ISO standard is intended to help improve the overall quality and usability of medical devices in markets around the world in order to lower the number of safety incidents involving medical devices that occur each year.

ISO 14155 can be read like a blueprint for moving through all the steps required to take a product from the beginning of a clinical study to the very end.  Compared to the original 2003 version and the follow-up 2009 revision, many of the revisions in the 2011 edition of the ISO standard deal with the safety evaluation of medical devices and improved reporting.  For example, ISO 14155:2011 expands the scope of the actions that medical device companies are responsible for when classifying and reporting adverse events and other safety data.  It also introduces the requirement that medical device manufacturers investigate and document device deficiencies in terms of how they could impact patient safety.

The International Organization for Standardization summarizes the key points addressed by ISO 14155:2011 as follows:

• Protect the rights, safety and well-being of human subjects
• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
• Define the responsibilities of the sponsor and principal investigator
• Assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.

The ISO standard has also been positioned as a way for medical device companies to compete more effectively on an international level, thanks to the institution of harmonized clinical investigation methodology.

MDCI will continue to stay on top of ISO and other industry-related standards developments and examine how they could potentially impact medical device companies of all sizes.

Benjamin Hunting
MDCI Blogging Team