Coating technology is exciting and provides a means for innovation and incremental improvements. We spoke with three individuals, all professors and one a surgeon, all at different stages of coating research.
Sterile E-Kits with updated instruments can be used with the company's plating system and with cannulated headed and headless compression screws. One E-Kit can reportedly replace the instruments in two trays.
MDR is a significant deviation from the MDD in that it requires you to conduct literature searches, postmarket surveillance and postmarket clinical follow-up in the 2017-2018 timeframe to comply with the regulation by 2020.
Smith & Nephew's CEO announced his intention to retire after seven years in the position. The Board is searching for his successor. Mr. Bohuon's tenure includes SNN's acquisition of numerous entities, most notably ArthroCare in 2014.
Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System.
We seem to never stop talking about it and finding new ways to establish compliance to 21 CFR, Part 820.100. I was reminded of this during a recent FDA inspection.
The move reflects a 30-year evolution from surgeon-founded entity, established to supply tissue for the treatment of bone tumors, to an organization that serves a range of providers and patients with research and development of new biologics to support tissue regeneration.