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- Precision Solutions | Precision Solutions Consulting

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. Our extensive experience includes PMA’s, Humanitarian Use Devices (HUDs), 510(k)s, managing IDE’s, deviolopment of clincal protocals and clinical monitoring. We provide a broad knowledge of regulatory standards including CFR, IEC, ISO, EN, NEMA, ANSI and UL. Precision Solutions is the source for the Quality and Regulatory Support your company needs.

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Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. Our extensive experience includes PMA’s, Humanitarian Use Devices (HUDs), 510(k)s, managing IDE’s, deviolopment of clincal protocals and clinical monitoring. We provide a broad knowledge of regulatory standards including CFR, IEC, ISO, EN, NEMA, ANSI and UL. Precision Solutions is the source for the Quality and Regulatory Support your company needs.
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- Precision Solutions | Precision Solutions Consulting | precisionsolutionsconsulting.com Reviews

https://precisionsolutionsconsulting.com

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. Our extensive experience includes PMA’s, Humanitarian Use Devices (HUDs), 510(k)s, managing IDE’s, deviolopment of clincal protocals and clinical monitoring. We provide a broad knowledge of regulatory standards including CFR, IEC, ISO, EN, NEMA, ANSI and UL. Precision Solutions is the source for the Quality and Regulatory Support your company needs.

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Validation Support | Precision Solutions Consulting

http://www.precisionsolutionsconsulting.com/validation-support.html

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation.

2

Audit Support & Preparation | Precision Solutions Consulting

http://www.precisionsolutionsconsulting.com/training-.html

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. Audit Support and Preparation.

3

US FDA Agent Representaion | Precision Solutions Consulting

http://www.precisionsolutionsconsulting.com/us-fda-agent-representaion-.html

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. US FDA Agent Representaion. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Responsibilities of Precision Solutions as your U.S. Agent. Assisting FDA in communications with the foreign establishment,.

4

Regulatory Compliance | Precision Solutions Consulting

http://www.precisionsolutionsconsulting.com/regulatory-submissions.html

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. We understant that it is important to keep the questions and review cycles to a minimum. We know how to structure the submission to reduce the number of documents to be submitted and to focus on key areas of reviewer questions. The Regulatory Compliance Services we offer are:. Investigational Device Exemption (IDE) for clinical studies. Quality System (QS) regulation.

5

Quality Systems | Precision Solutions Consulting

http://www.precisionsolutionsconsulting.com/quality-systems.html

Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation.

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Providing Quality and Regulatory Support to the Medical Device Industry. US FDA Agent Representaion. Audit Support and Preparation. Our extensive experience includes PMA’s, Humanitarian Use Devices (HUDs), 510(k)s, managing IDE’s, deviolopment of clincal protocals and clinical monitoring. We provide a broad knowledge of regulatory standards including CFR, IEC, ISO, EN, NEMA, ANSI and UL. Precision Solutions is the source for the Quality and Regulatory Support your company needs.

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