I will write your medical device cer, ber, and technical regulatory documents

Are you a medical device startup or manufacturer trying to get your product 

market-ready but stuck on the regulatory paperwork?

I'm a biomedical researcher with hands-on industry experience writing the 

exact documents regulators ask for: Clinical Evaluation Reports (CER), 

Biological Evaluation Reports (BER), Design History Files (DHF), and 

Technical Files for FDA, EU MDR, SFDA, and DRAP submissions.

I currently work in R&D for embolization devices, catheters, and monitoring 

systems, so I understand both the science and the regulatory language 

not just one or the other.

WHAT I CAN WRITE FOR YOU:

Clinical Evaluation Reports (CER) MEDDEV 2.7/1 Rev 4 structure

Biological Evaluation Reports (BER) ISO 10993 framework

Design History Files (DHF) FDA 21 CFR 820 compliant

Technical Files / STED documents EU MDR, SFDA, DRAP

Literature reviews & risk assessment documentation

Research proposals and patent drafts for medical innovations

WHY WORK WITH ME:

MS in Biomedical Sciences, real in vivo research background

Current Senior Research Specialist at a medical device R&D company

ISO 13485:2016 QMS & Internal Auditing certified

Familiar with FDA, EU MDR, SFDA, and DRAP requirements