b
bplussolutions

Pluus

@bplussolutions

EU MDR Regulatory Specialist CER and Technical Documentation Review

Turquía
Inglés, Turco
Parte de la información aparece en idioma inglés.
Sobre mí
I am an EU MDR Regulatory Specialist with over 10 years of experience in medical device compliance, clinical evaluation (CER), and technical documentation review. My work focuses on MDR Annex II & III assessments, CER compliance reviews, and structured gap analysis aligned with EU MDR requirements. I have worked at medical device manufacturers and experience working at Notified Body side, giving me insight from both sides of the regulatory process. I provide independent, objective MDR compliance evaluations to reduce potential findings before submission.... Lee más

Habilidades

b
bplussolutions
Pluus
desconectado • 
Tiempo medio de respuesta: 12 horas

Revisa mis servicios

Escritura técnica
I will review medical device mdr technical documentation