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Our Team. Why our Clients love to work with us.

Michelle Bonn, MBA

President and CEO

Michelle’s international business and medical manufacturing career has involved leading large-scale medical and industrial manufacturing projects across the US, Asia and Europe. She has led a variety of projects including; ISO-13485 certifications, medical device risk assessments, medical facility audits, FDA regulatory clearances, establishment registrations and Health Canada Medical Device License registrations. Her manufacturing expertise is focused on FDA Quality System Regulations, ISO standards and Six Sigma Quality methods.

She has worked in China, Hong Kong, Singapore, Iceland, Italy, Mexico, and the US.
She is a certified, Six Sigma Black Belt and holds an MBA with a focus on strategic planning.

Michelle has successfully completed RAPS medical-device regulatory certificate programs and is an active member of MedTech in Upstate New York.

Michelle’s forward thinking and bold, strategic planning abilities provide vision and direction for Guideline Medical. Watch the company move into new and innovative medical sectors. Her focus on early stage medical and biotechnology has shifted the company into exciting regulatory and medical industry territories. Her natural ability for raising operational and quality standards has led to consistent company growth.

Camilla Storaa, PhD, MBA

Director of Off-Shore Consulting and Manufacturing Operations

Dr. Storaa is the Guideline Medical engineering and Chinese manufacturing expert. Camilla’s background consists of medical device engineering, product development, medical device marketing and medical device manufacturing. Her knowledge of Asian & European culture and medical business practices are an asset to our company. She is able to guide you through the complex, global environment of medical manufacturing. Dr. Storaa has worked for large medical device organizations such as Maquet in Sweden and Mindray in China.

She is fluent in Mandarin Chinese, Swedish, Norwegian, German and English. She is the local presence you need when making or selling a medical device suited for a global market.

Camilla received her Engineering PhD from The Royal Institute of Technology in Stockholm, Sweden and an MBA from Tsinghua University in Beijing, China.

   

Robert O. Dean

Director of Compliance and Regulatory Affairs

Robert is the Guideline Medical Global, Regulatory Expert. Rob brings over 30 years of medical device, pharma, infection control and cosmetic manufacturing, compliance and regulatory experience to the table. Rob has worked for both large-scale and start-up regulated companies and has filed 6 patents during his career.  Rob has taught graduate level courses in FDA quality system compliance and regulatory affairs at Shanghai University, China.

He has successfully helped medical product companies work through the entire regulatory approval process, cleared numerous 510ks and registered medical facilities and products around the globe. Robert has extensive, hands on working knowledge of the US, European, Australian, Chinese, Canadian and South American regulatory systems.

Rob’s Manufacturing, Quality System Compliance and Regulatory knowledge is an asset to the Guideline Medical team. He can assure your medical products and manufacturing suppliers meet stringent, global compliance and safety standards.

Rob is the trusted resource you need if your company is ever faced with an FDA investigation, responding to 483s or FDA warning letters with a corresponding CAP (Compliance Action Plan). He will assure you are developing, implementing and communicating to the FDA in the most favorable way. Robert received his degree from the State University College at Buffalo.

 

Jean Bigoney, PhD, RAC, CQE

Director of Regulatory and Scientific Affairs

Dr. Bigoney is the Guideline Medical Scientific and FDA regulatory Expert. Jean has spent nearly two decades as a metallurgist focused on research for aerospace applications. In the 1990s Dr. Bigoney became involved with materials used in medical implants. As a titanium specialist, she worked together with surgeons to improve materials and surface treatments for biomedical implants, including artificial hip and knee joints, plates and screws for maxillofacial reconstruction, and dental implants, focusing on the issue of wear debris. She was instrumental in initiating a concentrated research effort on the “Interface between Material and Biosystem” (SPP 1100) of the German Research Society.  Her vast knowledge of lab testing and data analysis is vital to helping clients navigate FDA testing requirements.

Upon her return to the US in 2002 from the Technical University of Munich, Dr. Bigoney has been a registered US Agent with the FDA and began working with European based companies, looking to market their medical innovations to the US market. Jean has also worked with German and Canadian Medical Companies.  She has prepared and submitted numerous FDA, 510(k) applications, establishment registrations, written a variety of FDA regulatory road maps,  and understands the complexity of FDA regulatory requirements. Her strength for studying details is a real asset to Guideline Medical.

Jean is fluent in German and English. She has received both M.S. and PhD degrees in Engineering and Materials Science from Stanford University.