Take the User Survey:
Select the product line and fill out the form
This Survey aims to evaluate the clinical performance and safety of Mediphacos products that are on the market.
Target audience: Keraring Distributors and Importers.
This survey does not aim to assess satisfaction with the equipment or services provided by Mediphacos.
Time to complete a User Survey: Less than 3 minutes.
Post-market monitoring is a mandatory activity for manufacturers of health products in compliance with national and international standards, such as:
MEDDEV 2.12/2 Rev. 2, 2012 - Post Market Clinical Follow-Up Studies.
MEDDEV 2.12/1 Rev. 8, 2013 - Guidelines on Medical Devices Vigilance System.
MDR 2017/745 - Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
Resolução da ANVISA RDC Nº 67, 2009 - Dispõe sobre normas de tecnovigilância aplicáveis aos detentores de registro de produtos para saúde no Brasil.