Tag Archive for: Regulatory

Good Manufacturing Practices

Mayara Brunoro (Regulatory Affairs Specialist) today at MZF4: "Today was the day to give the GMP training Good Manufacturing Practices to the Mazzaferro Medical team. Proud to be a part and thank you for the opportunity!"

New customer area

Mazzaferro Medical is launching a new "customer area" on its website! Our customers will now be able to access all shipment documents, COAs, datasheets and regulatory reports using exclusive password. Now, it is possible to upload all the…

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…