I will develop iso 13485 documentation and eu mdr

Hello,

Welcome to my Gig,

Thank you for your interest,

Are you worried about the help needed for medical devices Documentation, Implementation, Training, Audit, and Certifications?

You have come to the right place.

As an engineer, I have served in the medical devices industry and worked in Certification and Consulting companies, so I do understand each and every aspect of the requirements, tasks, roots, directives, standards, and updates.

Feel free to ask me anything related. I will reply promptly.

Have any questions, I will answer.

Looking forward to hearing from you soon.

Documents generically required in ISO 13485 include:

Original Standard

Customized QMS for Medical Devices

Procedures

Policy

Job Descriptions

Work Instructions

Exhibits

Lists, Logs

Forms

Records

Moreover, I can help you with:

-Application of risk management to medical devices ISO 14971

-The ISO 10993 standards for evaluating the biocompatibility of medical devices

-Processes Validations, Passivation, Ultrasonic cleaning, Cleanroom, Sterilization, Vigilance, QA QC, Recall, Notify Body, Biocompatibility, Bioburden

-Risk Management ISO 31000, 22716

Medical devices registration in EU.