Dr. Kulisz is an experienced scientist-entrepreneur with an extensive U.S. and international experience. Multilingual with a broad knowledge of foreign standards, cultures and customs.  He holds PhD in technology development and applications of physics in medicine (Development of Medical Instrumentation -- Technology vs. Economics.)

He is also a registered naturopathic doctor in the US and accredited to practice medicine (natural medicine) in all countries of the European Union.  Dr. Kulisz is an acknowledged negotiator, organizer and effective planner.  He is also an experienced international traveler. 

Since 1983, Dr. Kulisz has been involved in all aspects of medical industry:

• Development of platform technologies and application-specific derivatives

• Assessment of technologies and target markets

• Development of business ventures/financing

• Approval and distribution of medical products world-wide

• Development and management of clinical trials and regulatory affairs

• ISO 9001/EN 46001, MDD, etc… registration, CE marking through established international accredited registrars and notified bodies

• Reimbursement approvals (although in the present economic situation worldwide, government reimbursement should not be considered a viable revenue option.)

• International negotiator

• Ad-hoc consultant to the Health Ministry of foreign government

• Medical instructor, lecturer, speaker, popular educator.

For Dr. Kulisz fee schedule click here

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BUSINESS AND TECHNOLOGY

• Development of new ventures

• Evaluation of product viability - technology and market economics

• Guidance to product developers and manufacturers

• New product development

• Definition and development of plans, specifications and limits for projects

• Industrialization of product designs

• Product feasibility studies and producibility reviews

• Implementation of ISO 9000/EN 46000, ISO 13485, ISO 9000:2000, QSR, MDD, etc.

• Development of standards and processes

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CLINICAL AND REGULATORY AFFAIRS

• Development of medical procedures

• U.S. and international clinical trials

• Clinical protocols

• Clinical trial sites

• Clinical monitoring, protocol enforcement and data analysis

• QSR, MDD, ISO 13485 and regional (international) compliance

• U.S. and international product approval

• Reimbursements (although in the present economic situation worldwide, government reimbursement should not be considered a viable revenue option.)

• Liaison to notified bodies and competent authorities

• Physician and clinical instruction

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MARKETING

• Development of foreign distributorships

• Development of marketing plans, objectives and training materials

• Distributor training

• Development and participation in conferences and conventions in the U.S. and overseas

To contact Dr. Kulisz, click here.

For Dr. Kulisz fee schedule click here

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