חברות העוסקות בפיתוח מכשור רפואי ומוצרי רפואה דיגיטליים נדרשות לתהליכי ולידציה כחלק מתהליכי האישור הרגולטורי. חשוב להכיר כי הדרישה לולידציה אינה מתייחסת רק למוצר עצמו ולתוכנות המהוות חלק בלתי נפרד ממנו. התקנים השונים, וביניהם תקן ISO 13485, שמים דגש גם על ולידציה של מערכות הניהול והבקרה בחברה. מערכות ממוחשבות, מערכות…

הטכנולוגיות בתחום המכשור הרפואי מתחדשות ומשתנות כל הזמן, ובהתאם גם דרישות הרגולציה. לאחרונה החל ה-FDA בצעדים לקראת רגולציה בינלאומית גלובאלית, אשר יקלו על יצרניות וחברות בקידום שוק המכשור הרפואי. כל המידע על ההצעה לתקנה שצפויה להביא לשינוי הדרישות בכתבה שלפניכם. הציפיות הרגולטוריות למערכת ניהול איכות התפתחו מאז יישום הרגולציה 21…

Regulation Guidelines for Cybersecurity In Medical Devices החידושים הדיגיטליים בעולם הרפואה מציבים סיכונים רבים למגזר הבריאות – פריצות, גניבת מידע מרשומות רפואיות, שינוי מינוני תרופות, שיבוש מכשור רפואי מוסדי ואישי ועד השבתת מערכות מצילות חיים. היום, כדי לקבל אישור רגולטורי מFDA  או/ו CE, יצרנים מחויבים לבצע תהליך ניהול סיכוני אבטחת…

Medical device manufacturers must establish quality and risk management processes and must rigorously follow them through the full lifecycle of the device. In addition, they must comply with all legislative requirements that apply to their target market.We decided to put together a guideline that you can use to understand and…

As medical devices become more advanced and the Software as a Medical Device (SaMD) industry booms, it is crucial to make sure your medical devices are cyber-secure. Like all technologies, anytime a medical device includes software, vigilance is required to become vulnerable to cybersecurity threats and attacks. The healthcare industry…

HIPAA is the most important legislation for anyone who wants to create healthcare-related software for the US market. While developing mHealth apps is complex, complying with HIPAA and even merely understanding all its requirements is a much more significant challenge. What is HIPAA? HIPAA is the Health Insurance Portability and…

Things You Should Do And Shouldn’t Do In Custom Software Development Software development companies experience more failures than successes, even when it is labeled as unique. This phenomenon makes it very important that your project is carefully planned and well-executed. With many years of experience in MedDev soft as a…

These days, software is essential in every area we can think of. It aids us in day-to-day, real-life activities, but treating software as a medical device is an entirely different matter altogether. Saving lives, boosting the quality of life and lowering healthcare costs are goals on a different scale. Over…

Health IT trends are constantly changing to meet the needs of healthcare organizations and providers. While these trends may pose certain concerns to security and patient privacy, it has also helped lead to greater opportunities to treat healthcare security more holistically while increasing the level of security at the same…

The Risks for Medical Devices All legally marketed medical devices have benefits and risks. The FDA allows devices to be marketed when there’s reasonable assurance that the benefits to patients outweigh the risks. Medical devices are increasingly connected to the Internet, hospital networks and other medical devices to provide features…

What is SaMD? The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medicalpurposes that perform these purposes without being part of a hardware medical device. This can comprise of software or applications intended to treat, diagnose, cure, mitigate or…

I would like to leave you with the text of forecasts made by a number of leading Harvard faculty on technologies that will characterize medicine in 2030, which was published in World Medical Innovation Forum program which took place on May 11. I feel it is important information or anyone…

This was one of most impressive virtual events that I’ve participated in over the last period. There were more than 11,000 attendees from 93 countries, 46 states, and 3200 organizations. I feel certain that communities were established surrounding many pressing topics, which will continue long into the future. World Medical Innovation…

Following my previous post, and attending, “Digital Health COVID-19 Response – Keeping Patients away from Hospital with no Compromise on Medical Services and Care.”, by Israel Export, I’m increasingly convinced that digitalization will be the solution for many of today’s challenges. 5 years ago, I too was skeptical that IoT…

In recent weeks, I have been attending many virtual conferences and webinars regarding the future of healthcare after COVID-19. What have I learned from these future speculations? Can we even begin to predict what will happen? Are things going to be different? (Spoiler: I would appreciate your input, comments, and…

About a decade ago, when I founded MedDev Soft, after many years of experience as a software engineer and manager at medical companies, I recognized the vast gaps between development and regulatory teams. Back then, there was one standard and few FDA guidelines which explained how to develop medical software.…

Since the existence of mankind there have been three major revolutions in history according to the book Sapiens (Telugu) by Professor Yuval Noah Harari: – The linguistic revolution – some 70,000 years ago – The Agricultural Revolution – About 12,000 years ago – The Scientific Revolution – About 500 years…

Today’s Corona crisis is rattling all sectors, not even sparing the often immune Medical and Pharma industries. It’s not simple to maintain the status quo when offices are closed and employees are home with their kids. The challenges facing the healthcare industry are many, but so are the business opportunities.…

We can not underestimate the importance of cybersecurity in today’s medical devices. Beyond a secure network, the UX/UI must be designed in a manner that is easy for medical staff to use and keep secure. We work closely with our companies to ensure that the features, usability, and regulatory processes…

We’re happy to share with you an article published at the beginning of the Covid-19 crisis, dealing with 5 ways how innovative Digital Health Technologies already make a difference in this field. We at Med Dev Soft not only keep being updated with the most emerging technological trends in the…

Is Digital Health Revolutionizing Cardiac Care? In this presentation, originally prepared for ICI 2019, I explore what to consider when considering exciting and cautionary technologies. Is Digital Health Revolutionizing Cardiac Care from Dina Sifri

There have been massive advancements and innovations in the healthcare industry, specifically in the development of medical devices, digital health, and other pharma-related solutions that can impact our everyday lives. Behind the scenes, companies go through long and complex processes to ensure they release a product that is proven to…