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.

Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – August 29-31, 2018 in Arlington, VA

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 info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5822

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 Navigating Regulatory Requirements

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems.

To register, go to http://www.aami.org/events/eventdetail.aspx?ItemNumber=6015


International Conference on Medical Device Standards – June 19-20, 2018 in London, UK

The AAMI/BSI International Conference on Medical Device Standards and Regulations is coming to Europe! During this event, government and industry leaders from Europe and the US will explore developments in international standards and regulations that are key to global market access and regulatory compliance.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5759