Quality managment and certification

CERTIFICATIONS

For.me.sa. is an ISO 13485 certified company.

We have adopted and certified our Quality Management System according to the ISO standard back in 2006 and since then For.me.sa. has maintained and renewed this certification. An important investment for us, which pushes us every time to surpass ourselves in achieving that quality perceived by our customers, which has made them loyal to our brand.
Indeed, perhaps more than any other type of product, the quality of medical devices has a direct impact on their effectiveness, as well as on the safety of patients and users and for this reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that is annually assessed and verified by a competent Authority in charge (Certifying Body).
Just in 2021, For.me.sa. renewed its ISO 13485 certification, passing, as per protocol, the annual visit conducted by an external Auditor appointed by its IMQ Certifying Body.

Product certificate

For.me.sa. is a manufacturer of the pessary for uterine prolapse, one of the company’s flagship products.
As a class IIb medical device and therefore of medium risk, the product and company are subject to annual checks and controls by their Certification Body. This is to ensure the marketing of a product that meets all the technical-regulatory requirements such as to be able to declare the product compliant and safe for its user.
For.me.sa., having always been firmly convinced in the importance of offering a high quality product, has certified his pessary for the first time in 1999.
Just two years ago, on the occasion of the 20 years of product certification, the company not only renewed the certificate, but extended it to two new pessary models: the rubber version without pigment and the rubber version without sterile pigment.
This extension, verified and approved by Kiwa Cermet, was designed by the company with a view to continuous improvement of its product to be offered to its customers.