ISO 13485
Frequently Asked Questions
How are your auditors trained?
Our Medical Device Auditors all have experience in the industry and maintain credentials for ISO 13485:2016 and country-specific regulations. Resumes and credentials are provided as part of the quotation package.
Do you have local and/or worldwide auditors?
Yes! We have many auditors in most major cities across the US as well as Central & South America, Europe, Middle East, South & East Asia. We have auditors that are well versed & seasoned in each industry that we serve.
How much is it going to cost?
Our flat-rate pricing ensures budgeting is easy and you can be assured there will never be additional or unexpected fees. It’s always fair & transparent.
When can you perform the work?
Typically 6 weeks or less. Audits of a longer nature may require some additional time to schedule.
What does the report look like?
We have fantastic reporting. Let us know if you’d like to see examples and we would be happy to provide them. We are also able to customize our report format to meet your needs, or work with something you already have established.
Medical Devices Audit Capabilities:
• ISO 13485:2016
• MDSAP – Medical Device Single Audit Program
• US FDA 21 CFR Part 820
• EU MDR
• ISO 14971 Risk Management
• IEC 60601 Electrical Equipment