Orthopaedic industry revenue reached $48.1 billion worldwide in 2016 and grew at 3.2%, ~$1.5 billion over 2015, according to our estimates, which have been published in our newest report.
Overall, 2,811 orthopaedic 510(k) clearances occurred between 2012 and 2016; of those, 76% were granted to U.S. companies. The five countries with the most 510(k)s following the U.S. were France, the U.K., South Korea, Germany and Switzerland.
Medical device companies have until March 1, 2019 to update their QMS to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed.
Many medical implant products and instruments created from stainless steel, titanium or cobalt chrome require UT evaluation to assure that the component is free from defects.
