ISO 13485 (Clause 8.4) - Periodic Safety Update Plan

you may also include work instructions

Including these documents in your QMS is essential for:

our templates ensure full compliance with ISO 9001:2015 standards

Maintaining Records: Ensuring that records of risk management activities are kept up-to-date and accessible for audits and reviews

Verification & Validation: Document verification and validation activities to confirm that your device meets regulatory and performance standards

Assign Responsibilities: Clearly outline who is responsible for raising and managing non-conformances

and issue date

Compliance Assurance: Using our template helps you maintain an effective batch history record

User-Friendly: With an intuitive layout and clear instructions

Detailed Record Keeping: Track when improvements were made and their outcomes

This template meets the required information needed on a declaration of conformity to medical device regulation EU 2017/745

These inputs include: