Quality Solutions and Support

Quality Success is the ability to improve with knowledge

Greetings
Hello, my name is Stephen Inglese, founder and CEO of Quality Solutions and Support. Our firm offers a wide spectrum of Quality and Regulatory support, both onsite and remotely anywhere in the United States and the world.
We provide the assistance to companies who are in compliance or seek to be in compliance with the FDA and ISO standards to include document preparation, Management Reviews and Internal Audits. In support of CAPAs, Non-conformities and Complaints, we can prepare a database to allow the ease of managing if so required. We also can prepare CE Mark Technical files to include device technical drawings and the US Food and Drug Administration (FDA) compliant design controls. Finally, we can provide your firm with Quality Improvement Process teaching. This seven (7) step process provides the basic fundamentals to improve the quality performance within your company. For example - identifying the need to improve, cause and effect analysis, implementation of effective corrective measures. This type of quality tool, improves the efficiencies for management to effectively manage day to day activities. We are skilled in assisting start-up companies with quality management systems from scratch as well as improving those in established device firms, including outsourcing and supplier audits

Quality Solutions and Support has over fifty (50) years of collective quality and regulatory expertise. I have had the opportunity to have studied with the Union of Japanese Scientists (JUSE) with the first American company that challenged and achieved the prestigious Deming Award. I have also demonstrated year over year positive results in working with inspecting registrars (TUV, BSI, and Intertek) and audits accomplished by the FDA. Our team includes the support of design engineers to laser and X-Ray compliance experts to ensure your companys needs are met. We also have the ability to translate in Chinese

Please contact me at 561.251.0876.
I look forward in talking with you soon to discuss your companys quality and / or regulatory needs.

I look forward in talking with you soon to discuss your companys quality needs.

Sincerely,
Stephen Inglese
Stephen W. Inglese
Founder and CEO
Quality Solutions and Support, LLC USA

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