I will do iso 13485 and regulatory compliance

Pakistan

I speak Urdu, English

Committed to excellence

I am good at technical writing, documenting and implementing related to medical devices. I have sound professional experience related to ISO standards and regulatory requirements of medical devices. A...

About this Gig

In this gig, I offer the following services:

- Gap analysis: I will review your existing quality management system and identify areas that need improvement to meet ISO 13485:2016 requirements.

- Documentation development: I will provide templates and guidance to help you create the necessary quality system documents, such as quality manual, procedures, and records.

- Implementation support: I will guide you through the implementation process, providing training and coaching as needed to ensure that your quality system meets the standard.

- Internal audit: I will conduct an internal audit of your quality management system to identify non-conformities and opportunities for improvement.

- Certification preparation: I will help you prepare for ISO 13485:2016 certification by providing guidance on the certification process and conducting a pre-assessment audit.

- Regulations requirement: as per the different regulatory affairs needs to make changes and classification of devices.