With accumulated experience since 2005, 4 Easy PRRC is immersed in the dynamic field of medical device regulation, IVDs and Software as Medical Devices, namely standalone software, invasive medical devices, active medical devices, Class D, C and B IVDs and various IVD tests based on PCR and RT-PCR techniques.

The background also extends to auditing Quality Management Systems in accordance with EN ISO 13485, RDC 16/2013 (Brazil), RDC 665/2022 (Brazil) and EN ISO 9001, navigating the various applicable standards, including ISO 14971, IEC 62366, IEC 60601, IEC 62304, IEC 82304, ISO 10993, ISO 14644, ISO 14155 and ISO 14648.

The team also has experience in: pharmacovigilance; preparation of clinical evaluation and biological evaluation reports for class I, class IIa and class IIb medical devices; pre-clinical and clinical studies; certification of devices in other territories, such as the USA, following FDA guidelines (510(k), De Novo Classification application, PMA); communication with notified bodies, competent authorities and CROs, ensuring compliance with regulatory standards; electromedical equipment certification processes, ensuring compliance with standards such as EC 60601-1, IEC 60601-1-2, IEC 62366, IEC 62304 and ISO 10993. This solid and broad background guarantees a quick and accurate response to the needs of regulatory representation (PRRC) for your business and products.