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How to Improve Resiliency in the Medical Device Supply Chain

Written by    Published in Blogs on 27 September 2019

Supply chain breakdowns in product quality, delivery or availability are major disruptions in the medical device supply industry. The importance of ensuring that the supply chain is running smoothly is obvious. Providing the best possible service without interruption takes precedence over all other considerations.

This white paper discusses how partnering with a value-based and ISO-certified supplier like Qosina can ensure supply chain resiliency, technical quality and cost efficiency.

Read the full post, and download the whitepaper here

Registrations versus Notifications for Medical Devices Europe

Written by    Published in Blogs on 19 September 2018

Notifications are published on EU Level after receiving the CE Approval

  • No legal obligation of the authorities to reply
  • Registration in several countries in Europe

In some countries in Europe there is an obligation of registration the Medical Device like: Italy, Portugal, France ,Greece ,Latvia

Japan Medical Technology Market Overview

Written by    Published in Blogs on 22 May 2018

The fast-paced aging society demands economical solutions especially for chronic disease care.

Aging Society

  • The percent of elderly (65+) Japanese will grow from 27% in 2015 to 32% in 2030 and 40% in 2060
  • The aging of the society puts tremendous strain on the economics of the healthcare system, since healthcare for the elderly cost more per capita than for the young.
  • Caring for chronic healthcare needs of the elderly is going to be critically important for Japan’s healthcare system and the society in general.

A Medical Device will be registered in Israel by an Israeli citizen or by a corporation registered in Israel- Israeli Registration Holder.

The validity of the registration in the Register will be determined according to various Registration Periods of the approvals – CE , ISO13485, FDA 510K etc..

Medical Devices which not always need registration in Israel are the following:

  1. Providing essential Medical Care
  2. Research
  3. Development & Production excluding marketing
  4. Medical Devices Use in Emergency status
  5. A Medical Device for export alone
  6. Clinical Evaluation
  7. Personal Use

Whether you are a medical device vendor or function in another regulated field, the document control process is an essential part of successfully launching a product. You have the option of using an archaic filing system riddled with a minefield of human errors, or an automated electronic system. So if you are at the point where you are under a significant workload, and wish to have better compliance with the regulatory authorities, such as FDA, CE, it is time to consider an electronic document control management system, an e-DMS (Electronic Document Management System).

Power supply & EMC coexistence in Medical space

Written by    Published in Blogs on 24 December 2016

Introduction

From gadget to vital, Connected Devices and Internet of Things (IoT) are everywhere and we see them gradually changing our lives throughout; the exponential development of small to large products embedding radio-transmitters is developing whilst creating some concerns, in terms of interferences and equipment disturbance, especially in the case of medical applications where it could have severe consequences!

כבר חזו כי, בתוך עשור, האינטרנט של דברים ( IoT ) יגדל להיקף של טריליונים של התקנים אלחוטיים וחיישנים. עם זאת, הצמיחה תהיה תלויה במידה מסוימת ביכולת של היצרנים להוזיל את העלות של מוצרים אלה. במקביל, עם זאת, התקנים אלה חייבים להיות מאופיינים היטב במהלך התכנון והפיתוח שלהם, ולאחר מכן להיבדק במהירות, בדיוק ובצורה חסכונית במהלך הייצור. כדי לפעול באופן אמין על קיבולת סופית של כוח הסוללה, מכשירים סלולריים זעירים אלה חייבים לצרוך הספק נמוך. זה דורש אפיון של צריכת החשמל של ההתקן בכל מצבי ההפעלה וכך לפתח יכולת להבין היכן למקד את מאמצי הפיתוח.

Closed System LOOP FDA Recommended CAPA Methodology

Written by    Published in Blogs on 04 November 2015

In this paper we are going to examine the quality of the event management process, and in particular
the CAPA, referred to as corrective and preventive action.
As we think about the quality management systems (QMS), and their different components, certainly
quality event management is one of the most important.
Additionally, as we look at the quality event management system more specifically, we see that it may
be broken up into primary components.

Read the Full Blog Here

בעת הזאת אנו עדים למהפכת הקונסיומריזציה של מכשור רפואי בכלל והנגשה של מכשירים דיאגנוסטיים בפרט לשימוש עצמי ובבית המשתמש. המגמה הזאת מונעת על ידי התפתחויות טכנולוגיות רבות עוצמה ובראשן המהפכה הדיגיטלית ומהפכת המידע המאפשרת שימוש בפלטפורמות ניידות סלולריות וסגירת מעגל עם סגל רפואי במהירות חסרת תקדים. הפיתוח של מכשירי IVD עובר מטמורפוזה ועלית המורכבות שלהם מציפה אתגרים חדשים בתחום הבטחת האיכות והרגולציה הדורשים ידע וכלים עדכניים. להלן מספר אתגרים אופיניים וגישות להתמודדות איתם.

Computer System Validation is the technical discipline that involves the use of life sciences companies, to ensure applications provide the information they were intended to. FDA monitoring and regulations evidence the need for strict quality measures, The Food and Drug Administration (FDA) which ensure specific controls and procedures during the Software Development Life Cycle (SDLC/ALM). Regulations such as those of the FDA also underscore the importance and need of not only following checks and procedures, but that these procedures are well documented. Said documents must be able to stand up to scrutiny by trained inspectors, especially since the financial penalties in the absence of an audit, can be exorbitant. Among the implications of not following relevant protocols in a Life Science Software application, include the loss of life. In applying the appropriate SDLC/ALM protocols such as documentation, are all part of the technical discipline of Computer System Validation. In effect, Computer System Validation involves what many IT people consider testing software.

Read the Complete Blog Here

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