DAVID O’CAEIRO

The life cycle of the medical device is a development process of the product, from its beginning to the end. The same applies to software that can represent a medical device (SaMD) or a medical device that has software as its part. Establishing the security and efficiency of such products requires knowledge of what the software...

When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the system fits for purpose.   Software validation process Validation for intended use...

A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a favorite place to keep important documents that need to be accessed by all. For example, standards, marketing documents, graphics used by all… endless reasons really. It’s the one easy-access place to...

qmsWrapper is a successful company promoting the organizational framework that provides structure to the processes, policies, procedures, and resources to implement the Quality Management System for medical device startups. Behind every successful company stands the skillful team. But the key role of such a team that leads to success is someone who is organized, passionate,...

Medical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them diagnose and treat patients. Despite its usefulness, they can pose a potential risk for human health. Therefore, they must be proved safe and effective. Medical devices Class I are generally not implantable invasive devices....

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 –...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

“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...

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...

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,...

Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet. “Wherever you've hidden it, we'll find it.” Audit Senior It's an audit day! In the beginning,...