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RK Pine Consulting

· ISO 13485:2003 – QMS requirements · FDA Quality System Regulations · Canadian Medical Devices Regulation including CMDCAS · Medical Device Directive (MDD) including CE Marking for Class I, II and II devices · Other supporting medical device and quality system requirements and guidelines including MEDDEV, GHTF and ISO standards

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· ISO 13485:2003 – QMS requirements · FDA Quality System Regulations · Canadian Medical Devices Regulation including CMDCAS · Medical Device Directive (MDD) including CE Marking for Class I, II and II devices · Other supporting medical device and quality system requirements and guidelines including MEDDEV, GHTF and ISO standards
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RK Pine Consulting | rkpconsulting.com Reviews

https://rkpconsulting.com

· ISO 13485:2003 – QMS requirements · FDA Quality System Regulations · Canadian Medical Devices Regulation including CMDCAS · Medical Device Directive (MDD) including CE Marking for Class I, II and II devices · Other supporting medical device and quality system requirements and guidelines including MEDDEV, GHTF and ISO standards

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Serving the medical device and diagnostics industries. We help clients to achieve compliance with US, Canadian and European requirements to gain market approval. Our objective is to help each client achieve balance between regulatory requirements and business practicalities. RK Pine Consulting is experienced at filling the voids in the regulatory affairs and quality assurance areas for developers, manufacturers and distributors. ISO 13485:2003 – QMS requirements. FDA Quality System Regulations.

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