Business
Futura receives positive QMS Audit Opinion
Futura receives positive QMS Audit Opinion.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n RNS Number : 5600V\n Futura Medical PLC\n 10 August 2020\n \n \n \n \n \n \n \n \n \n \n \n \n \n 10th August 2020\n \n \n \n \n \n Futura receives positive Quality Management Systems Audit Opinion for MED3000 under EU Medical Device Regulation\n \n \n \n \n Futura Medical plc (AIM: FUM) (\"Futura\" or the \"Company\"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce that it has received a positive audit opinion for its Quality Management Systems (QMS) from the relevant EU Notified Body in the European approval process for MED3000.\n \n In February 2020 Futura commenced formal proceedings for MED3000 to be approved as a medical device and a clinically proven treatment for Erectile Dysfunction (ED) in Europe by an EU Notified Body1. In order to obtain pre-marketing clearance within the EU under the new Medical Device Regulations (MDR), two requirements have to be met: Submission of Technical Documentation (TD) which includes sufficient efficacy, safety and quality data; and demonstration that the Company can operate to a high standard of quality through a Quality Management System (QMS). In receiving a positive audit opinion, the Company is pleased to announce that our QMS meets the required standard for the new Medical Device Regulations.\n \n The Company submitted the TD on MED3000 for review to the Notified Body as announced on 14th July 2020. With this positive QMS audit opinion it paves the way for the Notified Body to complete its review of the technical documentation. Futura continues to target a 2021 European approval date.\n \n \n James Barder, Chief Executive of Futura Medical commented: \"We are pleased to have fulfilled the key filing requirements for MED3000 for European approval as a clinically proven treatment for ED. In parallel with the regulatory processes and executing upon our strategic plans, Futura has now appointed specialised corporate advisers with international experience to facilitate commercial discussions with potential licensing and marketing partners.\"\n \n \n He added, \"We continue to see potential for MED3000 as an ED treatment in OTC markets as well as for...