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From concept, through design and commercialization, Pathway Regulatory Consulting, LLC provides regulatory and quality solutions for manufacturers seeking to market Medical Devices in the United States, Canada and the European Union. . We’ll work with you to:. Understand the value of your product to your customer and the claims you need to make to be successful in the market place. Develop the regulatory strategy to help achieve a successful and compliant product launch. Get your product to market!

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From concept, through design and commercialization, Pathway Regulatory Consulting, LLC provides regulatory and quality solutions for manufacturers seeking to market Medical Devices in the United States, Canada and the European Union. . We’ll work with you to:. Understand the value of your product to your customer and the claims you need to make to be successful in the market place. Develop the regulatory strategy to help achieve a successful and compliant product launch. Get your product to market!
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From concept, through design and commercialization, Pathway Regulatory Consulting, LLC provides regulatory and quality solutions for manufacturers seeking to market Medical Devices in the United States, Canada and the European Union. . We’ll work with you to:. Understand the value of your product to your customer and the claims you need to make to be successful in the market place. Develop the regulatory strategy to help achieve a successful and compliant product launch. Get your product to market!

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About us

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Turn on more accessible mode. Turn off more accessible mode. Skip to main content. 160;   . Adrienne Lenz, RAC. Over 16 years hands-on and leadership experience in Medical Device regulatory affairs and quality assurance as a consultant and with Smiths Medical PM, Inc. and GE Healthcare. Experience working with medical device development teams of all sizes in the US, Europe and Asia. Experience with a wide variety of active medical devices, including:. More than 25 510(k)s cleared by FDA. Regulatory and Q...

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Services

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Turn on more accessible mode. Turn off more accessible mode. Skip to main content. Regulatory strategy and submission. Development of regulatory strategy for US, Canada and Europe.  Guide development teams to design for regulatory compliance. US Premarket Notification 510(k) - required by FDA to offer for sale and ship in interstate commerce. US IDE (Investigational Device Exemption) required by FDA for clinical trials. Design Controls Specialist both hardware and software . Contract Review for Quality a...

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From concept, through design and commercialization, Pathway Regulatory Consulting, LLC provides regulatory and quality solutions for manufacturers seeking to market Medical Devices in the United States, Canada and the European Union. . We’ll work with you to:. Understand the value of your product to your customer and the claims you need to make to be successful in the market place. Develop the regulatory strategy to help achieve a successful and compliant product launch. Get your product to market!

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