Company Profile

Who We Are

JKS & Associates History

John Suzuki is the founder and principal of JKS & Associates. Mr. Suzuki is a 21 year industry professional with who has worked for one of the largest healthcare delivery organizations in the world. Prior to consulting, he has successfully developed medical devices and computational software for medical device and diagnostic products. In 1993, Mr. Suzuki started his consulting practice with other companies who needed assistance in developing and validating medical software and assistance in achieving ISO 9001 certification for software products. With his assistance, the Emulex Corporation in Costa Mesa, CA achieved TickIT (ISO 9000-3) certification. It was one of the first companies in Orange County to achieve TickIT certification and one of a small number of American companies to have achieved TickIT registration nationally. Today his practice covers many other areas of software development and software management.

What Makes JKS & Associates Unique

	Expertise in full lifecycle software development and medical software validation in a regulated industry (FDA).
	Cost effective and tailorable approaches and solutions for small and medium companies. We specialize in supplying complete software solutions for small and medium companies that don't have the resources or staff to complete full FDA-compliant software development and validation.
	Knowledgeable of multiple aspects of product development, including R&D, engineering, pre-production, manufacturing, release and maintenance.
	Knowledgeable of industry standards and models such as ISO 9001, ISO 9000-3/TickIT, GMP's, 510k's, MDD, CE, SEI CMM, Software Capability Evaluations (SCE's), ISO 12207, ISO 14971, AAMI SW 68, SPICE and ISO 15504.
	Expertise and broad knowledge in multiple business areas, such as finance, logistics, reliability, quality, manufacturing, process improvement, total quality management, enterprise resource planning (ERP), distribution, and material management.
	Extensive knowledge and training in the human side of software development and managing people.
	Proven consulting experience in medical, pharmaceutical, computer, software, banking, finance, and manufacturing industries.

JKS & Associates Personnel

From time to time, JKS & Associates utilizes the skills of other experienced software consultants and business professionals. Most of these individuals have worked with JKS & Associates previously and most of these associates tend to be highly skilled and experienced in their respective industries. Many of them have over 10 to 15 years of work experience in their respective domains. Some have written papers or presented at national meetings in their industry or teach classes frequently in their field. Some have advanced degrees as well. Their special talents and abilities are well known and understood by us. They provide additional resources and skill sets that can enhance and improve the relationship that we have with each client's unique needs. The use of these special associates allows us to draw on the individual skills of highly professional experts that would not be available to us or the client.

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