Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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.

AAMI Virtual Event: Medical Device Software Validation – May 31 – June 2, 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.

Program Objectives

At the conclusion of this course, you will be able to:

–  Explain the Requirements for Developing and Validating Medical Device Software including:

–  Laws – 21st Century Cures Act

–  Regulations – 21CFR820, EU MDR/IVDR

–  Standards – ISO 13485, ANSI/AAMI/IEC 62304:2006/A1:2015, ISO 14971, ANSI/AAMI/IEC80002-1:2009

–  Guidance – General principles of software validation, IMDRF SaMD, mobile medical app, cybersecurity premarket, cybersecurity    post market, AAMI TIR57 – Medical Device Security, Premarket Submissions from Medical Devices with Software

–  Explain the relationship between FDA and MDR Medical Device Classes, Software Safety Classes, and Software Development and Validation Activities.
–  Understand the required activities for developing and validating medical device software

–  Understand the FDA and EU Regulatory Submission requirements for the various classes of software

For more information:

AAMI Online Event – Medical Device Software Validation – May 23, 2023 & May 25, 2023 / 1:00 pm to 3:30 pm ET

The regulatory pace of change is accelerating for the in-vitro diagnostics (IVD) industry. Evolving regulatory standards impact IVD manufacturers, central laboratories, contract research organizations and manufacturers who bring new IVD devices to the commercial market or sponsor drug or medical device clinical trials that utilize IVD products as part of trial conduct. The In-Vitro Diagnostic Regulation (EU) 2017/746 significantly impacts all IVD manufacturers with approximately 80 percent of all devices in the European Economic Area now requiring some form of conformity assessment by a Notified Body. In Europe, major delays in the start of a device or drug trial can occur in some countries if there is a failure to consider the unique regulatory requirements for IVD devices in medical device or drug protocols.

This interactive course will provide new and intermediate learners with an overview of the United States and EU regulatory requirements for the development, commercialization, and clinical performance studies of in-vitro diagnostic (IVD) devices including the U.S. Code of Federal Regulations, US FDA guidance, ISO 20916, and the In-Vitro Diagnostic Regulation (EU) 2017/746.

Topics include the applicable US Food and Drug Administration and European Union regulations/directives, device classification system, clinical performance study considerations, commercialization routes, and submissions. The interactive course includes lectures, mini-quizzes, and small group case studies/examples to accommodate different learning styles in a safe learning environment.

For more info:

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: