Medical Device Regulatory Documentation Specialist Profile Description
Nigéria
Inglês
Algumas informações são exibidas no idioma inglês.
Sobre mim
Hello, I am Samuel, a biomedical engineering graduate and regulatory specialist helping med-tech companies clear compliance hurdles. I specialize in reviewing, repairing, and auditing medical device technical files, ISO 13485 SOPs, and GSPR checklists for FDA and EU MDR submissions. Having audited dozens of technical dossiers, I know exactly what notified bodies look for. Whether you need a gap audit or a full file update, I deliver audit-ready documentation tailored to your device. Let's make your device compliant... Saiba mais