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qmsWrapper Blog

Take Back Compliance

The Art of Managing Through Quality

What is considered by QMS planning in ISO 13485 – Lesson 5

What is considered by QMS planning in ISO 13485 – Lesson 5

This part of the standard explains why is planning so influential. Because without planning it's impossible to build quality into your medical device and company since the start. It's necessary to plan in such a way to ensure your QMS will be and remain effective. One of the ways you can assure that is through...
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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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Custom Templates according to your needs

Custom Templates according to your needs

Freshly made custom issue forms as a new driving force of your workflow, now build and design forms based on your business needs, your own self-designed templates all per requirements of the standard ISO 13485: 2016.
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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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qmsWrapper’s growth on the market

qmsWrapper’s growth on the market

Research on the global medical QMS software market in 2020 describes the supply and demand situation, market landscape, and competitive scenario. The analysis is focused on the current trends done under the supervision of business specialists.
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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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Cup of Joe #49 – Do You Need A Consultant?

Cup of Joe #49 – Do You Need A Consultant?

With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.
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Basic Terms in Medical Device Industry

Basic Terms in Medical Device Industry

We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases.
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QMS Manager role in MedDev industry

QMS Manager role in MedDev industry

A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.
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