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 Virtual Event – Human Factors for Medical Devices – March 14-16, 2023

Medical device manufacturers with robust human factors processes are leading the market, proving to have better clinical outcomes and better quality. Attend AAMI’s three-day Human Factors for Medical Devices training to understand critical human factors processes to consider when designing a medical device, how they affect its safety, and which steps to take to mitigate risks. Hear directly from FDA representatives from CDRH and CDER about the expectations for device usability, how best to conduct human factors evaluation and testing, the pre-market review process, and how strong human factors processes should be a part of the design and development of medical devices.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y4U00000IoALn

AAMI Virtual Event – Medical Device Software Validation – March 21-23, 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 registration and more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y4U00000IoAMq

AAMI Event: Integrating Risk Management to the Product Life Cycle – February 1 – 3, 2023

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y4U00000IoAKa