Business Consulting

Business Consulting

SUMMARY
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. He is also listed as an Expert to the European Commission.  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


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


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


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