ISO 13485 (Clause 7.5) - Servicing Protocol

The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1)

you must create a Product Information File (PIF) for each product and its variants

helps you establish actions to mitigate risks

Why Include a Complaints/feedback and reporting to authorities documents in Your QMS

This bundle contains:

Documents of external origin required for QMS purposes

Enhance Safety: Protect personnel and products from contamination-related hazards

Streamline Documentation: Organize and manage decontamination records in a standardized and professional manner

facilitating easier audits and certifications

and contamination control

to reduce or eliminate risks

components