risk management procedure
Please review posts Risk management terminology, risk management file before reading this post Risk management is supported by the following activities: Risk management Risk Assessment Risk analysis...
View ArticleRisk management terminology and characteristics
Basic terms Hazard: Potential source of harm (what can go wrong) Failure cause: what causes the hazard Harm: Physical injury or damage to the of people or property Risk: the calculation (RPN) of...
View ArticleQPack Risk Form According to ISO14971
Following is breakdown of each phase in the risk management process described in ISO 14971: 4. Risk Analysis 4.3. Hazard Identification Describe the hazard Select risk category Define the...
View ArticleALM 2.0 Methodologies for Software Companies
In this course we will review the various aspects of adopting and implemeting ALM methodologies and Tools in software companies. We will also learn several case studies and understand the process the...
View ArticleOrcanos 2013 Medical Device Industry Event
הכנס השנתי השישי לניהול תהליכי פיתוח במכשור רפואי 7.5.13 במלון השרון בהרצליה 07/05/2013 שיטות ודרכים להתמודדות עם רגולציה ותקנים בפיתוח מכשור רפואיאנו שמחים להודיע על קיומו של הכנס השנתי השישי של...
View ArticleOrcanos Cafe – Meet the FDA expectation by knowing their state of mind
Meeting CEO’s medical devices on the “dos and don’ts” with the FDA authority. Orcanos pleased to host Mr. Alan Minsk to meet CEOs of medical devices as part of Orcanos community practice for medical...
View ArticleMckit and Orcanos have completed a quality assurance project in Argo Medical
חברת מקיט מערכות השלימה פרויקט בחברת ארגו מדיקל “מערכת QPack Medical של אורקנוס פונה לסקטור התעשייתי העוסק בפיתוח מוצרים עשירי טכנולוגיה. המערכת נותנת מענה לחברות יצרניות בתחום המכשור הרפואי לסיוע...
View ArticleCore Study Cast Medical Technologies located in the USA selected Orcanos...
Orcanos Welcome Core Study Cast, Studycast®is a web-based medical imaging software that has been clinically proven to deliver the results that physicians, technicians, and administrators require....
View ArticleOrcanos 6th Medical Event – Regulation & Standards by Sherman Eagles
Presented by: Sherman Eagles Presentation Content: Recent regulatory activities Recent standards activities Emerging issues Medical device security Medical device interoperability Mobile medical...
View ArticleOrcanos 6th Medical Event – Accelerating Scrum for Medical Device development...
This presentation contains information about how Given Imaging implemented Agile Scrum into one of her flagged products, using QPack Medical. Presented by: Hagai Livni – Head of Software validation...
View ArticleOrcanos 6th Medical Event – ALM Implementation For Medical Device Vendor...
Presented By: Yael Sirpad R&D Project Development Manager Presentation Content: About Mazor Robotics Operation The Need for ALM system by rapid growing company Why ALM System? The Decision Process...
View ArticleIsraeli software firm Orcanos eyes drug sector to boost growth
TEL AVIV, June 18 (Reuters) – Israel-based Orcanos, whose software aims to help companies develop and produce products more cost-effectively, predicts its sales will grow by 25 to 30 percent annually...
View ArticleSoftware Maturity Performance
IEEE talks about changes made in the software, over 3 dimensions, to measure the maturity of the software, here in this post we wish to present the relation between test being performed (regardless to...
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