Call us today at 865.694.7517 | Email: Focus@FocusCVS.com
Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Loading...
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.
OUR SERVICES
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
CONTACT FOCUS CVS
OUR LOCATION
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.
NEWS AND EVENTS

AAMI Virtual Course – Design Control Requirements – Integrating the Quality System Regulation – July 15-17, 2026

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

For more information:  https://aami.org/event/design-control-requirements-integrating-the-quality-system-regulation-july26/

AAMI Event – 2026 World Medical Device Standards Congress Annual Meeting – April 13 – 14, 2026 in Leesburg, VA

Updated Event Details

Date & Time: April 13, 2026  |  1:00 – 5:00 PM

Location: Lansdowne Resort, Leesburg, Virginia, USA

What to Expect

This working session will bring together a focused group of standards leaders, regulators, and stakeholders to collaboratively:

  • Develop a formal WMDSC Charter to guide the mission and governance of future convenings
  • Establish Terms of Reference that define the scope, membership, and decision-making processes of the WMDSC community
  • Identify and prioritize key topics and themes for future WMDSC convenings over the next 3–5 years
  • Set the strategic direction that will ensure WMDSC remains a leading forum for advancing regulatory-ready medical device standard

For more information:  https://aami.org/event/world-medical-device-standards-congress/

AAMI Virtual Course – Process Validation Requirements & Industry Practices – April 8 – 10, 2026

This 3-day virtual course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.

For more information:  https://aami.org/event/process-validation-requirements-industry-practices-april26/