Orcanos Blog

Design Controls for Medical Devices: Regulatory Requirements and Software Best Practices
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August 16, 2026
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21
min read

Design Controls for Medical Devices: Regulatory Requirements and Software Best Practices

Zohar Peretz
Zohar Peretz
Co-Founder & US Lead at Orcanos
Design Control
Requirements Traceability Matrix for Medical Devices: A Complete Compliance Guide
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June 4, 2026
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30
min read

Requirements Traceability Matrix for Medical Devices: A Complete Compliance Guide

Design Control
The Best Quality Management System for Medical Device Companies: An Honest Evaluation
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May 18, 2026
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19
min read

The Best Quality Management System for Medical Device Companies: An Honest Evaluation

Choosing a QMS

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Differences between Quality Control and Quality Assurance
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April 23, 2023
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7
min read

Differences between Quality Control and Quality Assurance

Best Practices
Key Considerations for Successfully Implementing ALM Tools in Regulated Manufacturing Organizations
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April 1, 2023
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13
min read

Key Considerations for Successfully Implementing ALM Tools in Regulated Manufacturing Organizations

Best Practices
Top 5 tips for implementing test management successfully in your organization
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March 1, 2023
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25
min read

Top 5 tips for implementing test management successfully in your organization

Tips
21 CFR part 11 vs. EU Annex 11
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February 15, 2023
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4
min read

21 CFR part 11 vs. EU Annex 11

Regulations & Standards
5 tips helping evaluate RISK using ChatGPT
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February 11, 2023
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25
min read

5 tips helping evaluate RISK using ChatGPT

Tips
ISO 13485:2016 Sec. 8.5.2 – Corrective Action Adverse Effect
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July 14, 2020
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1
min read

ISO 13485:2016 Sec. 8.5.2 – Corrective Action Adverse Effect

Best Practices
SERVICING ACTIVITIES vs. COMPLIANT (ISO 13485 Chapter 7)
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July 13, 2020
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8
min read

SERVICING ACTIVITIES vs. COMPLIANT (ISO 13485 Chapter 7)

Regulations & Standards
ISO 14971:2019 ( Medical Device Risk management ) | Detailed explanation Cause by Cause
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July 9, 2020
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22
min read

ISO 14971:2019 ( Medical Device Risk management ) | Detailed explanation Cause by Cause

Regulations & Standards
Why Design Control Is Important For Medical Devices?
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April 11, 2020
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53
min read

Why Design Control Is Important For Medical Devices?

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