Showing posts tagged with: medical device

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...

With the aim to keep track of where healthcare technology is going, studying tech trends is essential. The MedDev industry is always looking for alternative ways to improve their performance, productivity, and efficiency in order to better identify, diagnose, and treat diseases.   SaMD   Software as a medical device (SaMD) is software that’s being used to improve medical...

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....

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...

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...

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...

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...

Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made.  It’s perfect for brand awareness, as well, as for promoting your business. There is so much benefit to attend a trade show. We have listed 10 trade shows in the world for 2020, which we believe has...

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...

There are countless benefits to implement a quality management system. We can all agree that an organization’s quality performance affects its bottom line. So, think of the investment in modern QMS software as an investment in preventing quality issues. How to choose the right software? The problem is with so many QMS software out there to choose from,...

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,...

An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance. How to create a Traceability Matrix? Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...