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Bovard Consulting | Regulatory | Medical Devices

Bovard Consulting provides regulatory services to the medical device industry. Services in employee safety are also provided.

http://www.bovardconsulting.com/

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Linda Bovard

Linda Bovard

29611 ●●●●●●s Road

Eu●●ne , Oregon, 97405

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Linda Bovard

Linda Bovard

29611 ●●●●●●s Road

Eu●●ne , Oregon, 97405

United States

1.54●●●●5431
li●●●●●●●●●●@yahoo.com

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Bovard Consulting | Regulatory | Medical Devices | bovardconsulting.com Reviews

https://bovardconsulting.com

Bovard Consulting provides regulatory services to the medical device industry. Services in employee safety are also provided.

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1

About Us

http://www.bovardconsulting.com/aboutus.html

Linda J. Bovard, Principal Consultant, has provided services to medical. Device companies for over. Years, more than. Years as a consultant. She has worked with entrepreneurs, virtual companies, start-ups,. Established small companies, and large conglomerates. Products range. From sophisticated electronic devices with software to IVDs to personal. She also conducts training courses for several Oregon institutions. Linda has a BA in Biology from Swarthmore College. She is Regulatory.

2

Services

http://www.bovardconsulting.com/recentprojects.html

Guided 510(k)s from concept to successful clearance to market. Recent. Projects have included neurological devices, electric wheelchairs, and. Audiology devices. Each project included developing a submission. Strategy, identifying predicate devices, reviewing labeling, writing and. Publishing the submission documents, and negotiating with FDA. Participated in a third party audit of a cardiovascular device study after. FDA questioned the integrity of the data. This included auditing raw. And activities, w...

3

Bovard Consulting | Medical Devices | Regulatory Services

http://www.bovardconsulting.com/services.html

For our medical device clients, we provide:. Any or all of these can be contained in a Preliminary Regulatory Assessment. PRA), an in-house document that lays out alternatives specific to your. Investigational Device Exemption (IDE). We can author a complete submission, provide one section, or review your. Evelop complete Quality System. Assist with improving or expanding your system. Udit existing system to FDA, ISO 13485, and/or Canadian. Conduct Quality System training.

4

Bovard Consulting | Regulatory | Medical Devices

http://www.bovardconsulting.com/index.html

Welcome to Bovard Consulting! Bovard Consulting provides regulatory services to. The medical device industry. We can provide comprehensive regulatory. Services or we can focus on specific projects, including. Assisting on an “as needed” basis. Any of these questions describe you:. Are you worried about your company's. Do you need to. That you have a. At critical phases in our. Company's growth, Bovard. Consulting has provided a bridge. Between our R&D strategy and. Regulatory requirements. They.

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Bovard Consulting | Regulatory | Medical Devices

Welcome to Bovard Consulting! Bovard Consulting provides regulatory services to. The medical device industry. We can provide comprehensive regulatory. Services or we can focus on specific projects, including. Assisting on an “as needed” basis. Any of these questions describe you:. Are you worried about your company's. Do you need to. That you have a. At critical phases in our. Company's growth, Bovard. Consulting has provided a bridge. Between our R&D strategy and. Regulatory requirements. They.

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