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

Kfir Peretz
Kfir Peretz
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

Compliance
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

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CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I
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July 7, 2019
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23
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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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12
min read

cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7

Compliance
Risk Management (03) – The Regulatory Requirements For Risk Management
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May 12, 2019
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13
min read

Risk Management (03) – The Regulatory Requirements For Risk Management

Compliance
cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7
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May 11, 2019
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9
min read

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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13
min read

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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25
min read

Current Good Manufacturing Practice (cGMP) and ISO 13485:2016 – Validation Master Plan (VMP)

Best Practices
Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?
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November 10, 2018
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7
min read

Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?

Best Practices
How To Measure Your Software Maturity Performance
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May 7, 2013
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8
min read

How To Measure Your Software Maturity Performance

Tips
FDA approves a framework similar to Orcanos that simplifies the CAPA process for medical device manufacturers, making it easier to implement.
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May 23, 2012
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12
min read

FDA approves a framework similar to Orcanos that simplifies the CAPA process for medical device manufacturers, making it easier to implement.

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