Orcanos Blog

Empowering Your Quality Management with AI-Driven Automation
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October 11, 2023
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5
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Empowering Your Quality Management with AI-Driven Automation

Empowering Your Quality Management with AI-Driven Automation

Rami Azulay
Rami Azulay
Founder & CMO
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Top 10 questions you need to ask any eQMS vendor for ensuring Regulatory Compliance: ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11
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July 8, 2023
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Top 10 questions you need to ask any eQMS vendor for ensuring Regulatory Compliance: ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11

Compliance
Embracing the Future: The Imperative Need for a Robust Quality Management System (QMS) in the Medical Device Industry in 2023
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July 4, 2023
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Embracing the Future: The Imperative Need for a Robust Quality Management System (QMS) in the Medical Device Industry in 2023

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Best Practices for Codification in Product Development
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May 29, 2023
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Best Practices for Codification in Product Development

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Why Design Control Is Important For Medical Devices?
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April 11, 2020
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Why Design Control Is Important For Medical Devices?

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How to Succeed in the Automotive Industry?
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January 19, 2020
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How to Succeed in the Automotive Industry?

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10 Tips To Ensure Your GMP is a Quality Priority
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July 29, 2019
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10 Tips To Ensure Your GMP is a Quality Priority

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CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I
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July 7, 2019
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CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I

Compliance
cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7
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May 30, 2019
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cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7

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Risk Management (03) – The Regulatory Requirements For Risk Management
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May 12, 2019
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Risk Management (03) – The Regulatory Requirements For Risk Management

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cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7
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May 11, 2019
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cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7

Compliance
cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7
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May 4, 2019
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cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7

Compliance
Current Good Manufacturing Practice (cGMP) and ISO 13485:2016 – Validation Master Plan (VMP)
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April 18, 2019
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Current Good Manufacturing Practice (cGMP) and ISO 13485:2016 – Validation Master Plan (VMP)

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