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DAVID O’CAEIRO

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The Wetling Company’s eQMS-journey

The Wetling Company’s eQMS-journey

We live in a time of technological evolution and the medical device industry is no exception. Technology advances day-by-day. The Wetling Company, with its revolutionary new wound-healing technology, is one such example. Their mission is to ease ailments caused by chronic and acute wounds, through a patented and revolutionary wound-healing method referred to as WMCS –...
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20 things you need to know about SOP for medical devices

20 things you need to know about SOP for medical devices

So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. But what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The aim...
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20 facts about FDA Approval Process for medical devices

20 facts about FDA Approval Process for medical devices

It is not easy for medical device manufacturers to face that torrent of information that awaits them when they need to face regulatory bodies and launch their device on the market.  Every company that plans to sell its medical device on US ground has to register with the FDA. In the following listing you will read...
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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. Typically, the medical device life cycle starts with an idea. The Idea maybe for a...
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It’s Official – MDR was postponed for a year

It’s Official – MDR was postponed for a year

The European Parliament voted to suspend the implementation of the MDR by one year. The decision to delay took into account the challenges of the coronavirus pandemic and the need for increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable.   On 25...
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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. Standardized classification and nomenclature of medical devices will serve as a common language for recording and reporting medical devices across the whole health system...
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QMS Manager role in MedDev industry

QMS Manager role in MedDev industry

ISO 9001 sets out the criteria for a quality management system. Quality Management System (QMS) ensures that an organization, product or service is consistent. It is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational...
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Best Medical Device startups based on AI in 2020

Best Medical Device startups based on AI in 2020

Innovation is a popular word in today's world. Sometimes it seems like if innovation is not included in anything you do, success will be absent. The medical device industry is continuously growing. Artificial intelligence (AI) research within medicine is growing rapidly as well. New technologies are keep growing along with new discoveries, so do the...
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Top 10 MedDev conferences and summits to attend this year 2020

Top 10 MedDev conferences and summits to attend this year 2020

Conferences, summits – why are they so important Well, there are many reasons to attend a conference. Regardless of the current COVID-19 outbreak, this does not mean that you shouldn’t plan the next step for growing your business.  One way of growing your business is by attending conferences. If you are attending, it’s more likely that you...
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The European Commission proposed MDR delay

The European Commission proposed MDR delay

The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unexpected pressures on economic operators, notified bodies and competent authorities. The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the...
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NEW MDR: May 2020 postponed

NEW MDR: May 2020 postponed

qmsWrapper has already written about the New EU Medical Device Regulation (MDR), and what you can expect when it comes into effect. Everyone is aware that all Medical Device companies that sell medical products in Europe must hold up to the new regulation. Companies that do not follow this regulation will not be allowed to...
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An effect of COVID-19 on upcoming  quality and regulatory interactions

An effect of COVID-19 on upcoming quality and regulatory interactions

COVID-19 is now in full swing. Its spread is felt through pressure on world healthcare organizations. Nonetheless, no delay in the regulatory approval of medical device products has been observed so far. Potential delays in regulatory communication and meetings will continue for months. 'Stay At Home' measures and the very limited allowable travel, with no...
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Medical Device Trade Shows after COVID-19

Medical Device Trade Shows after COVID-19

In a time when a lot of changes happen in a short time, we have to be quick and try to adapt to changes. Life does not stop, shows must go on! The majority of medical tradeshows are postponed, and we will help you be updated. Let us remind you why are tradeshows so important for every...
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The Ultimate Content List of Technical File for CE marking

The Ultimate Content List of Technical File for CE marking

You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information, we mean technical documentation. All those documents you have to have it in one place, organized, before providing the final EU Declaration of Conformity. A soon as you put together and...
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8 things to know about CE approval process for Medical Devices

8 things to know about CE approval process for Medical Devices

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few ways to do so, and it’s known as conformity assessment routes. We...
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5 things you must know about CE Mark

5 things you must know about CE Mark

CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know about the CE mark. In case you are MedDev Start-up, planning to...
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How CAPA should be verified?

How CAPA should be verified?

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...
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4 steps how to carry out RCA

4 steps how to carry out RCA

Why? Where? How? When? What? Most problems don’t have obvious solutions. That’s why they remain problems, and that’s why, it’s necessary to be aware of underlying causes, especially when planning to carry out a root cause analysis. Root cause analysis is basically a process with a systematic approach for identifying a problem. It provides companies a way to prevent...
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Top 20 Medical Device Conferences and Trade Shows 2019

Top 20 Medical Device Conferences and Trade Shows 2019

The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, expand your industry contacts, recruit new employees, explore new product offerings, keep up on the latest regulatory trends,...
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Pitfalls and Best Practices in Establishing a Quality Manual

Pitfalls and Best Practices in Establishing a Quality Manual

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In this article, we will discuss how to establish, operate and maintain a good one: Introduction (what is a QM, and what should include) Common mistakes in establishing a QM, and how to avoid them Pro...
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Do you know how secure your documents really are?

Do you know how secure your documents really are?

Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (e.g. hurricanes, floods, fire) or uncontrollable human errors, power surges, technical malfunctions and increasingly malware attacks. You need a backup plan and the ability to restore your data quickly. Warning steps through infographics While...
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Advantages of Cloud Based QMS and Project Management Software

Advantages of Cloud Based QMS and Project Management Software

Advantages in numbers Every industry or organization is working hard to achieve success and to ensure their service and product safety. Nowadays, it is hard to imagine the work without an electronic, cloud-based QMS or project management tool.  Cloud-based tools are the most searched software today, they are easy to obtain through the internet, they are flexible,...
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