Take the user survey:
This survey aims to evaluate the clinical performance and safety of Mediphacos products that are on the market.
Target audience: Ophthalmologists using intraocular lenses, Keraring, contact lenses and Medilon.
This survey does not aim to evaluate satisfaction with the equipment and services provided by Mediphacos.
Time to complete the User Survey: less than 3 minutes.
Post-market monitoring is a mandatory activity for manufacturers of health products that comply with national and international standards, such as:
MEDDEV 2.12 / 2 Rev. 2, 2012 - Post-marketing clinical follow-up studies.
MEDDEV 2.12 / 1 Rev. 8, 2013 - Guidelines on the medical device surveillance system.
MDR 2017/745 - Regulation 2017/745 of the European Parliament and of the Council, of April 5, 2017, on medical devices, which modifies Directive 2001/83 / EC, Regulation (EC) No 178/2002 and Regulation ( CE) no 1223/2009 and repealing Council Directives 90/385 / CEE and 93/42 / CEE.
EN ISO 13485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
ANVISA RDC Resolution No. 67, 2009 - Provides the techno-surveillance standards applicable to health product registration holders in Brazil.