I will provide qms and technical documents as per eumdr 2017 745

The documentation includes device description, intended use, design and manufacturing information, risk management, clinical evaluation, post-market surveillance, and more, ensuring full compliance with EU MDR 2017/745.

Yes, I can classify medical devices into appropriate classes as the documentation requirements vary based on the device's classification.

I develop QMS documentation tailored to your processes, ensuring they meet ISO 13485 standards, covering aspects like quality policies, procedures, and records for consistent product quality.

The timeframe varies depending on the complexity of the device and the specific documentation required. I strive to deliver high-quality documentation promptly, meeting your deadlines.

Yes, I can assist with preparing and submitting documentation to regulatory bodies to help you achieve market approval for your medical devices

Absolutely, I tailor each document to meet the specific needs of your device and regulatory requirements, ensuring a personalized approach for each project.

I offer complete medical device regulatory services, including compliance with FDA, Health Canada, Saudi Food and Drug Authority, and worldwide regulatory services.