Quality Standards and Best Practices
Code of Federal Regulations Title 21 – Part 11 (CFR 21-11)
Our products and services meet the FDA”s set of requirements for electronic records for reliability, privacy, traceability and safety.
CE marking is a mandatory conformity marking for placing Class I-III medical devices on the market in Europe. Our Medical Devices guarantee the CE marking requirements in its Declaration of Conformity.
Organic Law on the Protection of Personal Data (LOPD)
Through an external audit, Grupo Pulso obtains an annual certification of compliance with the requirements stipulated in the Organic Law of the Protection of Personal Data.