Skip to content

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.

Related Resources

RQS Logo

What To Do (And What Not To Do) When You Receive a FDA Audit Notice

Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate its commitment to patient safety and regulatory compliance. By…

READ MORE
RQS Logo

Internal Audits & Annual Physicals: Is Ignorance Really Bliss?

What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual internal audit and annual physical examination are both important,…

READ MORE

Software as a Medical Device (SaMD) Audit Challenges

Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer just physical “devices”, but more in the form of…

READ MORE

Related Tools & Templates

Subscribe to our Newsletter
Join our mailing list for the latest Rook events, thought leadership, and more.
Back To Top