Client Endorsements

We are extremely grateful for the recognitions & endorsements of our clients and we hope to include you among them.

Instrumentation Laboratory

1995 Letter of appreciation for my commendable performance from Instrumentation Laboratory, Italy, Vice President/Quality Assurance, World Wide, James C. McGaha, Jr. (IVDs).

Instrumentation Laboratory

Medtronic Heart Valves

1996 Letter from Medtronic Heart Valves for the valuable recommendations and inputs to their system and for helping them better understand the regulatory requirements and plan for the implementation of the New Quality System Regulations (Heart Valves, Tissue and Mechanical).

Medtronic Heart Valves

Regulatory Affairs Consultant

1995 Letter of appreciation for my quality and professionalism from Regulatory Affairs Consultant, Glen A. Dunki-Jacobs. (Phacoemulcification Devices)

Regulatory Affairs Consultant

University of Puerto Rico

1986 Outstanding Young Men of America for religious and professional contribution at the University of Puerto Rico, Regional College Administration, submitted by Jorge Valentin, Dean for Student Affairs.

University of Puerto Rico

Venusa, Ltd.

1995 Letter of appreciation for my valuable information from Venusa, Ltd, Italy, President /CEO, Cesare Gagliardoni (IV Sets).

Venusa, Ltd.

Laboratory Prodimed

1995 Letter of appreciation from Patrick Bouveret, Plant Manager for my quality and professionalism from Laboratory Prodimed, France (Endometrial Suction Curette).

Laboratory Prodimed

Pegasus Research Corporation

1993 Letter of appreciation for my thorough and probing investigation from Pegasus Research Corporation, President, Kenneth G. Miller. (Humidifiers)

Pegasus Research Corporation

Global Harmonization Task Force

1997 FDA Cash Award for exceptional service as a Team Leader, for performing several high priority PMA/510(k) assignments and for my participation with the Global Harmonization Task Force auditing cadre.

Global Harmonization Task Force

Johnson & Johnson

2009 Letter of recommendation from Johnson & Johnson, for providing compliance consulting services.

Johnson & Johnson

Guidant Co.

2003 Letter of recommendation from Guidant Co. (Catheters/Drug Delivery Systems)

Guidant Co.

ASP

2009 Letter of recommendation from ASP for consulting services related to performing a comprehensive gap analysis and redesign of company’s Design Control process.

ASP

Medtronics Anurex

1999 Letter of appreciation from Medtronic Anurex facility. As a result of my audit the facility passed a FDA pre-PMA inspection without FDA-483s.

Medtronics Anurex

Medtronic Heart Valves

2007 Letter of appreciation for an excellent job in identifying weaknesses in company system, providing constructive solutions, clearly explaining the FDA interpretations of various clauses in the regulations, and allowing the staff to experience the interviewing techniques of a FDA investigator. Staff was comfortable with his conversational and interviewing style.

Medtronic Heart Valves

Willy Rusch

1997 Letter of commendation from Willy Rusch, Germany, for my thorough inspection and extremely thorough analysis and grasp of their processes (catheters).

Willy Rusch

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.

Download vCard