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 Virtual Event: Design Control Requirements – Integrating the Quality System Regulation – February 12-14, 2024

This intensive 3-day, hybrid (in-person or virtual) 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.my.site.com/s/lt-event?id=a1Y4U00000JuRLL

AAMI Event – Medical Device Software Validation – November 7-9, 2023

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also challenge you with real-life exercises to give you experience in determining the different classes of software and the activities required for developing and validating that software.

For more info:  https://www.aami.org/training/training-suites/software-cybersecurity/medical-device-software-validation

AAMI Virtual Event: Integrating Risk Management into the Product Life Cycle – October 3-5, 2023

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=a1Y4U00000IoSSL