Orcanos Blog

Design Controls for Medical Devices: Regulatory Requirements and Software Best Practices
Calendar Icon - Technology Webflow Template
August 16, 2026
Clock Icon - Technology Webflow Template
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
Calendar Icon - Technology Webflow Template
June 4, 2026
Clock Icon - Technology Webflow Template
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
Calendar Icon - Technology Webflow Template
May 18, 2026
Clock Icon - Technology Webflow Template
19
min read

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

Choosing a QMS

Latest Articles

AI in Quality
Choosing a QMS
Quality Processes
Design Control
Regulations & Standards
Best Practices
Tips
Orcanos News
How to Succeed in the Automotive Industry?
Calendar Icon - Technology Webflow Template
January 19, 2020
Clock Icon - Technology Webflow Template
6
min read

How to Succeed in the Automotive Industry?

Best Practices
10 Tips To Ensure Your GMP is a Quality Priority
Calendar Icon - Technology Webflow Template
July 29, 2019
Clock Icon - Technology Webflow Template
34
min read

10 Tips To Ensure Your GMP is a Quality Priority

Tips
CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I
Calendar Icon - Technology Webflow Template
July 7, 2019
Clock Icon - Technology Webflow Template
23
min read

CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I

Regulations & Standards
cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7
Calendar Icon - Technology Webflow Template
May 30, 2019
Clock Icon - Technology Webflow Template
12
min read

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

Regulations & Standards
Risk Management (03) – The Regulatory Requirements For Risk Management
Calendar Icon - Technology Webflow Template
May 12, 2019
Clock Icon - Technology Webflow Template
13
min read

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

Regulations & Standards
cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7
Calendar Icon - Technology Webflow Template
May 11, 2019
Clock Icon - Technology Webflow Template
9
min read

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

Regulations & Standards
cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7
Calendar Icon - Technology Webflow Template
May 4, 2019
Clock Icon - Technology Webflow Template
13
min read

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

Regulations & Standards
Current Good Manufacturing Practice (cGMP) and ISO 13485:2016 – Validation Master Plan (VMP)
Calendar Icon - Technology Webflow Template
April 18, 2019
Clock Icon - Technology Webflow Template
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!?
Calendar Icon - Technology Webflow Template
November 10, 2018
Clock Icon - Technology Webflow Template
7
min read

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

Best Practices
Trusted by