Rizwana B

Clinical Evaluation Trainee @Dr.Klinisch Research Pvt Ltd

Bengaluru, IN

As a Clinical Evaluation Trainee, I contribute to the preparation of Clinical Evaluation Plans (CEP) and Reports (CER) in compliance with EU MDR 2017/745 and MEDDEV/MDCG guidelines for Class I, IIa, IIb, and medical devices.My responsibilities include: Preparing clinical evaluation checklists and gathering required information from clients. Ensuring CERs meet current regulatory requirements and industry standards. Identifying and describing the state-of-the-art of medical devices. Conducting systematic literature searches and analyzing clinical data to demonstrate device safety, performance, and equivalence. Reviewing adverse event reports and product recalls from global vigilance databases (MAUDE, MHRA, TGA, etc.) for post-market surveillance. Collaborating with cross-functional teams to collect and incorporate supporting documentation.

St.Paul Matriculation Higher Secondary School

10th (SSLC)

Sun Institute of Pharmaceutical Education and Research

Doctor of Pharmacy - PharmD, Pharmacology

St.Paul Matriculation Higher Secondary School - Kurinjipadi (tk) Cuddalore (Dt) Tamilnadu.

12th (HSC)