Call us today at 865.694.7517 | Email: Focus@FocusCVS.com
Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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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 Course – Design Control Requirements – Integrating the QMSR – October 6 – 9, 2025 – Dublin, Ireland

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-qmsr-dublin-ire-oct-2025/

AAMI Virtual Course – Integrating Risk Management into the Product Life Cycle – October 1 – 3, 2025 – 9 am to 6 pm ET

Event Overview

(Three 8-hour days from 9:00am-6:00pm EST)

Join us a develop a comprehensive understanding of risk management concepts used throughout the quality management system to consistently meet FDA 21 CFR 820 regulations and ISO 13485 requirements utilizing ISO 14971 and ISO 24971. Attendees will learn how to use risk management files and risk analysis concepts to make risk-based decisions for medical device product realization and other quality management system process decisions throughout a device’s lifecycle.

Benefit from the insight of AAMI Faculty and FDA representatives as you learn detailed risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management using ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO TIR24971:2020.

This course will cover risk management principles used throughout the lifecycle of a product (design, manufacturing, post-production, and retirement). Instructors will also identify linkages between risk management processes and quality system processes. Participants will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards.

For more information:  https://aami.my.site.com/s/lt-event?id=a1YUW00000FIUTd

AAMI Virtual Event: The Quality Management System Regulation – August 18-22, 2025

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to implement and maintain a risk-based quality management system that complies with FDA’s amended 21 CFR 820 and the Quality Management System Regulation (QMSR).

For more info:  https://aami.my.site.com/s/lt-event?id=a1YUW00000FHh7y