Experienced • Effective • Affordable

Clients get better results through outsourcing - FDA submissions, procedure writing, validations, internal auditing, employee training, complaint handling (MDR), and CAPA projects.

AUDITING SERVICES

The Quality Systems Investigation Technique (QSIT) is an inspectional process used by the FDA to assess a medical device manufacturer’s compliance with the Quality System Requirements and related regulations.

We conduct audits:

At key suppliers
To prepare for an FDA inspection
To improve one or more of the QSIT modules shown
After receiving a FDA 483
Due diligence prior to acquisition
To prepare the business for sale

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Washington, DC 1-202-241-3407

Chapel Hill, NC 1-919-942-1634

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FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Services.

AUDITING SERVICES

The Quality Systems Investigation Technique (QSIT) is an inspectional process used by the FDA to assess a medical device manufacturer’s compliance with the Quality System Requirements and related regulations.

We conduct audits:

At key suppliers

To prepare for an FDA inspection

To improve one or more of the QSIT modules shown

After receiving a FDA 483

Due diligence prior to acquisition