I will develop pms, ber, rmr, cer reports for medical devices

I have over 20 years of regulatory affairs experience in the medical device industry and specialize in providing high-quality and compliant Clinical Evaluation Reports (CERs) in accordance with MEDDEV 2.7/1, Medical Devices Directive 93/42/EEC, and the new EU Medical Device Regulation 2017/745.

I am an expert in developing CERs for Class I, IIa, and IIb devices while ensuring compliance with MEDDEV 2.7/1, Article 61 of MDR 2017/745, Annex 10 of MDD 93/42/EEC, and MDCG 2020-5 guidance. The CER plays a crucial role in the CE marking of your medical device and in responding to feedback from notified bodies.

I will:

• Create a Clinical Evaluation Report in compliance with MEDDEV 2.7/1 rev. 4 and MDR 2017/745.
• Create a PMS Report.
• Create a risk analysis in compliance with ISO 14971.
• Create a biological evaluation report in compliance with ISO 10993-1.
• Create an MDR reporting document according to the MDR regulations.

 I am at your service, so please feel free to place an order now.