CMC MEDICAL DEVICES & DRUGS, S.L. Obtains ISO 13485:2016/A11:2021 Certification, Reaffirming Its Commitment to Quality and Safety in the Medical Industry
CMC MEDICAL DEVICES & DRUGS, S.L., a company dedicated to regulatory affairs and representation of medical devices, is pleased to announce that it has obtained the ISO 13485:2016/A11:2021 certification, an internationally recognized standard that defines the requirements for providing services for national and international regulatory affairs, as well as Authorized European Representative services for Medical Devices and In Vitro Diagnostic Medical Devices.
ISO 13485 “Medical Devices – Quality Management Systems” is the globally recognized standard for quality management systems in the medical device sector. This certification ensures that an organization’s quality management system meets the rigorous standards required by the industry, generating trust and ensuring compliance with medical device regulations.
In the words of Manuel Mateos, CEO of CMC MEDICAL DEVICES & DRUGS, S.L.:
“Obtaining the ISO 13485:2016/A11:2021 certification is a source of great pride for our company. This recognition not only reinforces our position as industry leaders but also validates our continuous efforts to ensure that our services meet the most stringent standards of quality and safety. This achievement is the result of the hard work and dedication of our entire team, who have demonstrated an unwavering commitment to excellence. We are confident that this advancement will allow us to continue offering innovative and safe services to our clients, while expanding our presence in the global market.”
ISO 13485:2016/A11:2021, the most recent version of the standard, is recognized worldwide as the reference norm for manufacturers and representatives of medical devices. This certification guarantees that CMC MEDICAL DEVICES & DRUGS, S.L. has implemented a robust quality management system that complies with the applicable regulations and legal requirements in the markets where it operates.
Achieving this certification not only strengthens the trust of customers and business partners in the company but also opens new opportunities in regulated markets, where compliance with ISO 13485:2016/A11:2021 is a prerequisite for the commercialization of medical products.
CMC MEDICAL DEVICES & DRUGS, S.L. will continue its commitment to continuous improvement, ensuring that its services not only meet but exceed market expectations, further strengthening its reputation as a reliable provider in the medical device industry.
