| SUMMARY Dr. Kulisz is an
experienced medical researcher, experimental clinician, business developer, and scientist/entrepreneur with an extensive U.S. and
international background in medical industry, clinical trials, medical applications of science,
and economics.
Multilingual with a broad knowledge of foreign standards, cultures and customs. He has
degrees in economics, science, and medical technologies. He is also a
licensed naturopathic physician. Dr. Kulisz is an acknowledged
negotiator, organizer and effective planner. He is also an experienced international
traveler. Accredited to practice medicine (natural medicine) and have
right to work in all countries of the European Union.
Since 1983, Dr. Kulisz has been involved in all aspects of medical
industry:
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Assessment of medical technologies,
treatment methods, and markets
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Development of business ventures and
financing
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Development of medical products, instrumentation and devices for specific national
markets
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Approval and distribution of medical products world-wide
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Development and management of clinical trials and regulatory
affairs
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ISO 9001/EN 46001, MDD, etc… registration, CE marking through established
international accredited registrars and notified bodies
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Reimbursement approvals
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Assistance with patent/trademark protection through the associated American patent
law firm specializing in medical product patents and trademarks.
For Dr. Kulisz fee schedule click
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MEDICAL TECHNOLOGIES INDUSTRY
Dr. Kulisz's medical technologies expertise is reflected by his first-hand experience
in the following fields:
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BUSINESS AND TECHNOLOGY
- Development of new ventures, partnerships, mergers and acquisitions
- International business
- Development of business plans and financing
- 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
- 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
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