Preparing for audits can be challenging, but Rook Quality Systems ensures you're always ready. Our expert team provides comprehensive audit support, from internal audits and supplier evaluations to FDA and ISO audit preparation. We help identify compliance gaps, implement corrective actions, and streamline your quality system to meet regulatory requirements with confidence.

Our Audit Services

• Internal Audits
• Supplier Audit
• FDA Inspection Preparation 
• ISO 13485 Certification 
• EU MDR / MDSAP Certification Support

The Value of RookQS Audit Support

• Team of Auditors – We have over a dozen Certified Auditors on our team who can provide expert guidance on how to ace your next audit and prepare your team on proper audit etiquette. 
• Proven Track Record – The RookQS team has supported countless medical device companies of all device types in preparing for a regulatory audit, with a high track record of our clients achieving zero inspection findings.
• Efficient Compliance Guidance - Our team is well versed in supporting clients who need last minute assistance in preparing for an audit, with instances of some audits notices received only 2 business days in advance. The RookQS team of quality consultants is ready to assist as soon as you need, ensuring you are ready to successfully conquer your next audit.