ISO 13485 Certification of medical devices

Mera Medical Solutions achieves a rigorous standard in less than 12 months

Mera Medical Solutions has been certified since June 2023, according to ISO 13485 - the internationally recognized quality management system for medical device manufacturers. The accreditation was granted after a successful audit by the certifying company SGS - Société Générale de Surveillance SA.

Following significant investment in the optimization of the harex® device, the company has seen an increase in demand for this solution for men suffering from urinary incontinence. Mera Medical Solutions uses its expertise to constantly refine processes and as a result, the company offers a highly effective solution.

The company continually seeks to invest in the improvement process to increase the benefit to its customers, and with a growing number of customers coming from the medical device sector, the achievement of ISO 13485 demonstrates its commitment to this important and growing market.

"Mera Medical Solutions has focused on obtaining a quality management system relevant to each major market and customer," said Peio Tomé, CEO of Mera Medical Solutions. "Securing ISO 13485 was the next step for our international development and shows our commitment to not only meet, but exceed the needs of a growing customer and partner base. We are very proud to have achieved this rigorous and prestigious standard in less than 12 months."

ISO 13485 was conceived to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery of medical devices that are safe for their intended use.

ISO 13485 certified companies communicate a commitment to quality to both customers and regulators and is a tangible demonstration of the fact that Mera Medical Solutions is capable of producing safe and effective medical devices that meet the regulatory requirements of its customers. Mera Medical Solutions is one of the few manufacturers of medical devices for the management of male urine leakage to be ISO 13485 certified.