Medical Device Internal Audit Support

It’s far better to identify any issues or gaps in your QMS during an internal audit than in front of the FDA or ISO. The internal audit process is critical to emerging medical device companies to ensure that your Quality System is effective and compliant for the size and scope of your company.

Regulatory bodies worldwide require medical device companies to conduct internal audits. But many medical device companies struggle keeping up with the constant updates and new guidance documents for MDR, FDA, ISO, and other regulatory agencies.

RookQS has a seasoned team of 11 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.

What is an Internal Audit for a Medical Device?

An internal Audit for medical devices is a process conducted by organizations that design or manufacture medical devices. During this process, an auditor will check the compliance of the procedures to the selected regulatory regulations and standards. They will also check on the records and compliance with the procedures.

Example of Items Internal Audits Should Include:

Quality management system
Risk management
Product development
Design control
Production and process control
Labeling and packaging
Complaint handling
Records and documentation
Medical Device File
Management Review
Work Environment
Supplier records
Installation, sterilization, and other manufacturing processes
Traceability
Analysis of Data
CAPA

Rook’s Certified Auditors will conduct internal or supplier audits, and provide critical support during an external or regulatory audit, including FDA, MDSAP, ISO, and MDR.

RookQS’ team has completed over 100 remote internal audits, and can assist your team in completing your audit in the timeliest and most efficient manner. We believe strongly in the effectiveness of the internal audits being a key indicator for the overall status of the QMS. Internal audits are an ideal tool for consistently improving both your QMS and your compliance.

The key to no findings is simple: finding the right partner. Look to Rook.