Kaye Suzuki Device Consulting, LLC

We provide realistic and reliable business and compliance solutions for medical device manufacturers that are planning or building products which benefits the patients, healthcare systems and authorities and associated medical businesses in Japan.

We believe quality is an essential foundation for everything we do.  We believe quality is especially important in the healthcare industry where lives depend on the quality, skill and integrity of everyone involved.  We work closely with each and every client to assure we are their preferred strategic partner for conducting business in Japan.

We will accomplish this in a way that:

• Creates an environment of learning and sharing as a global team with our customer;
• Enables our customer to have confidence in managing Japan with full visibility, understanding and control; and
• Aspires of the highest standards of compliance and ethics for the benefit of all stakeholders
  

Our recent Consulting accomplishments include:

• Supervising successful upgrade of a previously submitted Shonin application for a new medical device to meet the regulators' expectation for approval;
  
• Supervising successful preparation of a major partial change Shonin application for upgrade to PAL reform standards that included all the changes made in the last 10 years;
• Supervising successful preparation of a reimbursement application to gain a favorable pricing for a new medical device;
• Supervising successful QMS audits by PMDA.

Our wider portfolio of technical consulting services include:

• Market Research
• Market Entry Strategic Planning
• Product Development
• Market Release Authorization Holder (MAH) License
• Product Market Release Approval (Shonin)
• Foreign Manufacturer Accreditation
• QMS and GCP Audits
• Commercial Partner Management
• Reimbursement
• Pos-market compliance activities to comply with GVP, GQP, GPSP and QMS
• Due Diligence
• Opportunity Assessment
• General Management
• Turnaround, Troubleshooting
• Product Quality Improvement
• Quality System

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Our people

Keisuke Kaye Suzuki

Principal

Kaye has over 19 years of experience in Japan.  He began his career in product development, advanced to roles in sale & marketing and completed the quality system cycle with a corporate leadership role in regulatory & quality. 

Prior to founding his consulting practice, Kaye was the executive vice president, director and chief regulatory and quality officer (Seizou Hanbai Soukatsu Sekininsha) for Guidant Japan K.K. between 2004 until late 2006 after Boston Scientific acquired Guidant.  In this executive role, Kaye was responsible for shephering all regulatory, clinical, quality, vigilance and compliance efforts in Japan.  He also was a leader medical affairs through operation of the Institute for Therapy Advancement-Japan . 
Kaye joined Guidant in 1998 as senior marketing manager of vascular interventions business for Japan.  His corporate career was distinguished by a swift progression of increasing responsibilities that included leadership as a senior. director in Japan regulatory and quality arena that challenged him to reengineer a black box organization to be in compliance with the PAL reform and also be transparent for the business units.  Prior to Guidant, Kaye worked for Cordis of Johnson & Johnson K.K. and for a Japanese device company where he managed a variety of products, all except orthopedics as project manager and product manager. 

Before entering the healthcare industry, Kaye was the first Asian-American to own and operate an air carrier in the mainland US.  He has been an entrepreneur since age of 15.  Kaye was born in Japan, grew up in Europe and the United States. He holds BS & MS in Bioengineering from UC San Diego.