Welcome to Focus Compliance & Validation Services
Core Regulatory Compliance & Validation Services
Focus Compliance & Validation Services provides consulting services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, and auditing; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

Webinar – Technical Considerations for Additive Manufactured Medical Devices – January 10, 2018

On January 10, 2018, the FDA will hold a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.

For more details:


Hurricane Irma 2017

To all of our friends, clients, and associates being impacted by the wind, rain, storm surge, and flooding from Hurricane Irma, please know we are thinking of you and praying for your safety. Whether you are evacuating or hunkering down to wait it out, stay safe and stay strong, #FloridaStrong, #Irma2017.


Quality System Requirements & Industry Practice Course, June 2017, Instructor Focus’ CVS Mark Walker

Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Austin, TX, June 9-12, 2017.  The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation.  For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=4116