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Global Medical Device Consultant, Medical Device Expert and Strategist - Tina Lochner

Medical device expert with engineering, science and business degrees, 20 years experience in the medical, pharmaceutical, biotech, and regulatory industry who worked with companies around the world.

http://www.tinalochner.com/

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Global Medical Device Consultant, Medical Device Expert and Strategist - Tina Lochner | tinalochner.com Reviews
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Medical device expert with engineering, science and business degrees, 20 years experience in the medical, pharmaceutical, biotech, and regulatory industry who worked with companies around the world.
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1 Medical device expert
2 Medical device lead auditor and product certifier
3 Medical device auditor and inspector
4 Medical device regulatory consulting
5 Biomedical device engineering and testing consultant
6 medical device audits and approvals
7 global regulatory compliance
8 quality management system conformity
9 Medical device strategis
10
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Global Medical Device Consultant, Medical Device Expert and Strategist - Tina Lochner | tinalochner.com Reviews

https://tinalochner.com

Medical device expert with engineering, science and business degrees, 20 years experience in the medical, pharmaceutical, biotech, and regulatory industry who worked with companies around the world.

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1

Blog - Tina Lochner

http://www.tinalochner.com/blog

Welcome to my blog! Welcome to my blog! I also would like this blog to become a platform for two-way communication between other consultants and subject matter experts to spark new ideas and ways of thinking. I most certainly don’t claim to know it all I can only tell you what I feel works, provide interpretation, and give you access to information I find helpful along the way. Three Apocalyptic Horsemen of Quality Management Systems. Posted by Super User. User Rating:  5. 160;/  5. Herd behavior, and.

2

Education - Tina Lochner

http://www.tinalochner.com/work/education

Master of Business Administration, May 2009 GPA 4.0. University of Maryland University College MD / USA. Master of Science in Biotechnology, May 2007 GPA 4.0. University of Maryland University College, MD / USA. Inducted into Phi Kappa Phi Honor Society. Bachelor of Engineering in Biotechnology, February 2001. Hamburg University of Applied Sciences Germany. Current member of DECHEMA (Society for Chemical Engineering and Biotechnology). Student representative to Faculty Search Committee. Production line w...

3

STRENGTHS - Tina Lochner

http://www.tinalochner.com/work/strengths

Holistic thinker making high quality, timely, efficient decisions based on pertinent facts. Strong work ethics; integrity; maintenance of high standards (quality of work) and commitment. Disciplined, self-management focused and self-motivated. Creative problem-solver; high level of flexibility, effective time management and planning.

4

SKILLS & CERTIFICATIONS - Tina Lochner

http://www.tinalochner.com/work/skills-certifications

Notified Body, ANSI-RAB NAP, and Health Canada recognized certified EU MDD 93/42/EC and IVDD 98/79/EC, Canadian MDR (CMDCAS), Japanese PAL, and QMS (ISO 13485, ISO 9001) Lead Auditor. FDA trained 510(k) reviewer, working knowledge of cGMP / GLP. AAMI certified to evaluate requirements and industry practices related to US FDA QS Regulations for medical device and drug manufacturers; current knowledge of understanding changing FDA enforcement focus. Native speaker German; fluent English; basic French.

5

Summary - Tina Lochner

http://www.tinalochner.com/work/summary

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Global Medical Device Consultant, Medical Device Expert and Strategist - Tina Lochner

Global Medical Device Consultant and Strategist. Global Medical Device Consultant and Strategist. Global Medical Device Consultant and Strategist. Global Medical Device Consultant, Medical Device Expert and Strategist, Manager and Director QS Compliance. Success is not final, failure is not fatal: it is the courage to continue that counts. Winston Churchill. Successful evaluation of an organization’s quality management requires in-depth knowledge and understanding of business constraints, audit strategie...

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