At Versa Biomedical we work every day to support our customers in the development of preclinical solutions that add value to their scientific and technological projects. Under this commitment, we are pleased to announce that we have obtained the ISO 13485 certification, an international recognition that accredits our quality management system in the field of medical devices.

What is ISO 13485 and why is it so relevant?

ISO 13485 is the reference standard for quality management systems applied to the medical device industry. It certifies that an organisation meets the regulatory and quality requirements necessary to design, develop and manufacture safe, effective and consistent products under a strict regulatory framework.

For a Contract Research Organisation (CRO) such as Versa Biomedical, specialising in ad hoc pre-clinical biomedical models, this certification not only guarantees operational excellence, but also reinforces our commitment to the highest standards in the healthcare and pharmaceutical sector.

One more step towards our purpose: Open Models, Open Futures

This milestone reinforces our proposition: to create open models that drive open futures. Futures where biomedical research is more accessible, efficient and personalised. It allows us to continue to evolve as a trusted partner to biomedical, pharmaceutical, biotech and medical device companies, offering preclinical solutions designed with scientific rigour, regulatory focus and forward thinking.

Each step we take – such as obtaining ISO 13485 certification – reinforces our commitment to quality, excellence and accountability. We understand that these standards are not only a regulatory requirement, but the basis that allows us to accompany our customers with guarantees, agility and confidence in the development of biomedical solutions.

This certification shows that at Versa Biomedical quality is not just a requirement, it is a conviction, and that our vocation is clear: to be a driving force for health and innovation at the service of global progress.