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Take Back Compliance

The Art of Managing Through Quality

Control of nonconforming products in ISO 13485 – Lesson 18

Control of nonconforming products in ISO 13485 – Lesson 18

The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfill its specified requirements like customer or regulatory requirements. It’s important to be identified as soon as possible. Plus, ISO 13485:2016...
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Customer-related processes – Lesson 11

Customer-related processes – Lesson 11

qmsWrapper explains how and why is important for you to keep to a high standard of your medical device or service that you offer to customers. About requirements and it’s a review of the way of communication.
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Understand ISO 13485 - Lesson 1

Understand ISO 13485 - Lesson 1

ISO 13485 for everyone - Simplified, explained, chapter by chapter - quality management system for medical devices! start with lesson 1.
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5 FAQs about ISO 13485

5 FAQs about ISO 13485

What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.
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The Wetling Company’s eQMS-journey

The Wetling Company’s eQMS-journey

Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS. By offering the latest cloud-based eQMS solutions, qmsWarpper is their support in quality.
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Post-market surveillance (PMS) of medical devices

Post-market surveillance (PMS) of medical devices

As the medical device's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user. To meet these needs, manufacturers should take a risk-based approach when considering clinical and medical device post-market surveillance requirements.
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What is medical devices lifecycle

What is medical devices lifecycle

The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in the middle, and what is considered the end will be explained in this article.
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