Do you ever wonder how you’d measure up if the FDA or a notified body came knocking?
If this thought keeps you awake at night, SpectraMedEx can help you rest easier. We audit quality systems, design files, and risk management protocols in search of shortcomings.
Along the way, we often uncover elements you don’t want: duplication, unnecessary practices, and processes that don’t add value. Getting rid of them now – before the real FDA or notified body comes calling – can yield big benefits later.
With more than three decades of medical device industry experience, SpectraMedEx knows what’s required and, as importantly, what’s extraneous. We can audit exactly to standards, to expectations, or to industry best practices.
There’s more to the story. Vendors sometimes request a look at quality systems and other pieces. Having everything aligned correctly can get the vendors you want, on your side.
As an independent auditor, SpectraMedEx will review your internal controls so you’re prepared for your next interaction with the FDA or a notified body. No sense losing sleep over it in the meantime, is there? So let us help you with:
- Quality System Audits (cGMP / 21 CFR Part 820, ISO 13485, ISO 9001)
- Design Control Audits
- Mock FDA Audits
- Technical File Audits
- Design History File (DHF) Audits
- Vendor Audits
And if needed, we can help you with your remediation efforts too.