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Hector Guestrin, PhD - Medical Devices, QMS & Regulatory Affairs Consultant

Medical Devices, QMS & Regulatory Affairs Consultant

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Hector Guestrin

Hector Guestrin

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Hector Guestrin

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Hector Guestrin, PhD - Medical Devices, QMS & Regulatory Affairs Consultant | hectorguestrin.com Reviews
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Medical Devices, QMS & Regulatory Affairs Consultant
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1 Medical Devices
2 Quality Management Systems
3 QMS
4 Regulatory Affairs
5 FDA
6 ISO 13485
7 Health Canada
8 Product Lifecycle Management
9 PLM
10 Verification & Validation
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standards and regulations,consulting services on,medical devices,qms documentation packages,qms training,requirements management,design control,verification and validation,biomedical engineering
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Hector Guestrin, PhD - Medical Devices, QMS & Regulatory Affairs Consultant | hectorguestrin.com Reviews

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Medical Devices, QMS & Regulatory Affairs Consultant

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1

Standards and Regulations - Hector Guestrin, PhD

http://www.hectorguestrin.com/standards-and-regulations.html

Hector Guestrin, PhD. Services for Medical Device Companies. The following are fundamental documents needed to implement a Quality Management System, establish a Regulatory Affairs framework and develop medical devices. Standards for medical devices. AAMI TIR36:2007 - Validation of software (tools) for regulated processes. ANSI AAMI ISO EC57:1998-(R)2008 - Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. SOR-98-282 - Medical devices regulations. Health Ca...

2

About - Hector Guestrin, PhD

http://www.hectorguestrin.com/about.html

Hector Guestrin, PhD. Services for Medical Device Companies. Middot; Medical Devices. Middot; Quality Management Systems. Middot; Regulatory Affairs: FDA Regulations; Health Canada and European Union Standards. Middot; Product Lifecycle Management. Middot; Risk Analysis. Middot; Process, project and people management. Middot; Requirements Management. Middot; Quality Assurance. Middot; SW Configuration Management. Middot; SW Verification and Validation. Middot; HW Validation. Middot; Digital video products.

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