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The revised ISO 13485 is intended to maintain non-negotiable levels for quality and safety requirements, but one expert says the standard has gone too far in an attempt to satisfy everybody involved in quality management systems. Read More
Johnson & Johnson is restructuring its cardiovascular, orthopedics and surgical businesses, with an eye toward streamlining operations and speeding up the pace of innovation. Read More
The ISO’s standard for measuring exposure to ionizing radiation has been updated, taking into account the new limit on equivalent dosing to the lens of the eye, as recommended by the International Commission on Radiological Protection. Read More
Devicemakers finding themselves having to change postmarketing requirements or other commitments need to inform the FDA and other regulators as soon as possible if they identify gaps in their plans. Read More
Speaking at AdvaMed 2015, FDA Associate Director for International Affairs Kim Trautman renewed her call for participants in the International Medical Device Regulator Forum’s single audit pilot program, saying devicemakers have proven reluctant to join. Read More
Where will the medical technology industry be in five years? That question takes center stage in a new report by Evaluate Medtech, which predicts a global market of about $478 billion in 2020. Read More
The FDA hasn’t seen the expected number of industry participants in the Medical Device Single Audit Program pilot, and is hoping to attract volunteers as it eyes a Jan. 1, 2017, launch date. Read More