The new ISO 13485 is applicable across the whole supply chain and will address the entire life cycle of a medical device. The final standard is expected to be published in March 2016. Consider these eight changes when updating your certification.
A power shift to payors and providers, intense regulatory scrutiny, unclear sources of innovation, new delivery models and a need to serve lower socio-economic classes are disrupting the orthopaedic device market. OMTEC Keynote Speaker Bill Tribe previews actionable advice for industry in this pre-OMTEC interview.
As we approach OMTEC 2016, BONEZONE will take a closer look at the types of exhibitors you will meet, to help you identify your next new partner. Laser Processing makes up 15 percent of the total core capabilities offered by the 131 confirmed companies.
When you view the graphs and accompanying list, you´ll discover that job responsibilities are rooted in product development and commercialization. We expect to see sales and marketing titles represented in 2016, as roles and responsibilities expand.
Unique Device Identification (UDI) and sterilization will be driving influences for orthopaedic device packaging in 2016 and beyond. With increased regulatory guidelines in the form of FDA's UDI guidance on convenience kits, along with tightening price pressures, the way device packaging is done will change.
Pure-play spine companies are driving the market's growth. In doing so, they are demonstrating that differentiated and innovative products and the presentation of clinical data, all focused on one market segment, is a successful strategy to capture market share from segment-diverse competitors. More.