5091 Lawler Avenue
Fremont, CA  94536
Phone: 510-894-4162

Karen Bielinski – President

Karen’s experience encompasses over 25 years in the healthcare and medical device industry.  She has coordinated US and international studies with independent contractors, field engineers and contract research organizations.  Her background in surgical critical care and cardiac electrophysiology provides a unique perspective to her extensive industry experience.  In addition, she has specialty knowledge of class II and III medical devices for the following therapeutic areas:
cardiovascular surgery, rhythm management devices (pacemakers and implantable defibrillators), left ventricular assist devices, sleep apnea, aesthetic laser applications and various ancillary devices. 

Her experience includes working with large, mid-size and start-up companies in the various therapeutic specialties.  Her skills encompass the planning, monitoring and management of clinical trials including pre-clinical support activities for Good Labor Practices (GLP) and non- GLP studies.  Her coordination and management skills include budget oversight, protocol and consent development, Institutional Review Board and Ethics Committee submissions, data review, findings analysis and report writing.

She is proficient in product development activities incorporating FDA and ISO Quality System regulations.  She is adept in the preparation and submission of PMA, IDE, CE and 510(k) applications as well as the completion of product reports.

Education/Certifications
B.S.N. Saginaw Valley State College, University Center, Michigan
Registered Nurse, State of Michigan (for 24 years)
Continuing Education: Participation in educational seminars, academic courses and professional meetings.

Memberships and Affiliations
Regulatory Affairs Professional Society   
American Heart Association
Association of Clinical Research Professionals  
Project Management Institute
Heart Rhythm Society (formerly NASPE)

Karen is happy to complement her services with established vendors or additional consultants you prefer.

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