Staying in Compliance:
Medical Devices

You don't need any regulatory surprises from your manufacturing process — especially those that result from lack of adherence to quality standards.

We can help you establish or review your processes to reduce the possibility of such surprises.

Our services include:

Audits

	Conducting In-house and Vendor QSR Audits
	Conducting Mock FDA QSR/CGMP, GCP & GLP Inspections
	Conducting ISO Audits
	Performing Due Diligence Audits

Electronic Registration and Listing

	Electronic Facility Registration
	Electronic Product Listing

Training

Conducting in-house training for QSR and ISO

Part 11 Compliance

Computer Validation

QSR/CGMP Compliance Support

	Assisting in Developing Design Controls and Validation Requirements
	Assisting in Developing Quality System Requirements
	Resolve QSR/CGMP Problems

US FDA Agent for Foreign Companies

Please contact us for additional information or to get help now!