Tag Archive for: Regulatory

Brazil Roadshow 1

Visiting Razek, Biomecanica, Engimplan, TechImport and Traumec during our roadshow this week in São Paulo (Brazil). Thanks for the kind welcome! Mayara Brunoro | Regulatory Affair Specialist Alexandre Fuzinelli | Innovation and…

Product Regulation

Mazzaferro Medical aims to gain FDA 510K clearance on its products for Sports Medicine (endobuttons, all suture anchors, needled round and tape sutures) on the 1st semester of 2021. With a robust regulatory system and ISO13485:2016 Quality Management,…

Sports Medicine Products

Mazzaferro Medical started up a benchmark facility producing 300MM meters of sutures. There’s an area designed to produce 30MM meters of UHMWPE round, tape and variable geometry tapes sutures for the Sports Medicine and another to…