Posts by zoharp

Orcanos QMS: Regulation Compliance & Governance Engine

August 7th, 2017 Posted by Document control, IEC 62304, IEC60601, ISO 13485, ISO 14971, regulation compliance 0 thoughts on “Orcanos QMS: Regulation Compliance & Governance Engine”

Orcanos is about to launch its QMS-Regulation-Compliance engine as part of Orcanos integrated ALM and Quality Management Software System.


Compliance best practices lie at the heart of all standards-based regulations and good quality management, such as ISO 14971, IEC 62304 and ISO 13485. However, it is a challenge to keep compliance without electronic QMS, or using traditional ALM tools, as most of them are R&D driven, and lack the support of the quality management software system. Compliance remains a leading concern for regulated industries such as Medical Device, Pharma and automotive.

Orcanos QMS Compliance engine

The powerful new capabilities of Orcanos Compliance Engine would simplify the way companies govern and control quality and regulations, and will provide a “Virtual Auditor” that would scan the project data in respect for specific industry regulation, and quality best practice, such as compliance with ISO 14971, IEC 62304 and ISO 13485 and more.

Orcanos QMS Compliance Engine is a flexible tool that allows companies define any regulation in a simple Excel or Google Sheet, defining the standard, section, classification in case of medical device (CLASS I, II, III), Remediation, and many other parameters, ans then import these regulations into Orcanos ALM and QMS platform and connect it to their projects records.

Orcanos QMS Compliance Engine then scans project data based on the specific regulations, and specific logic attached to it, and shows the faults in a graphical presentation. Together with Orcanos dashboard and notification mechanism we provide quite a good control and monitoring platform

Defining a compliance audit item

Define any compliance audit, setup and customize each compliance item

Compliance Audit

Running a compliance audit check

This is an example of an “Virtual Auditor” that inspects the compliance of specific product with the ISO 14971.

Running Compliance Audit Check


ORCANOS Deploys Google Material Design for Orcanos ALM 2017 UI / UX

November 18th, 2016 Posted by Software Lifecycle Management 0 thoughts on “ORCANOS Deploys Google Material Design for Orcanos ALM 2017 UI / UX”

All about our users…


Comply with Google Material Design to create a visual language that synthesizes classic principles of good design with the innovation and possibility of technology and science

Well, in other words – we want to make our end user feel comfortable with Orcanos technology

Material is the metaphor

A material metaphor is the unifying theory of a rationalized space and a system of motion. The material is grounded in tactile reality, inspired by the study of paper and ink, yet technologically advanced and open to imagination and magic.

Surfaces and edges of the material provide visual cues that are grounded in reality. The use of familiar tactile attributes helps users quickly understand affordances. Yet the flexibility of the material creates new affordances that supercede those in the physical world, without breaking the rules of physics.

The fundamentals of light, surface, and movement are key to conveying how objects move, interact, and exist in space and in relation to each other. Realistic lighting shows seams, divides space, and indicates moving parts.

Ref: From Google Material Design


To get new users up and running quickly is a real challenge. Orcanos invested in building on-boarding wizard, that based on industry sector and needs, provides templates and how-to’s to start with. These templates are based on Orcanos 12 year extensive experience with ALM and Quality procedures.

Right from the beginning, the on-boarding UI was detailed to assure user adoption and good experience.

orcanos software onboarding



Main screen colors & structure are adjusted in a way so user that spends hours in front of the computer would feel comfortable. So relaxing colors, minimize the controls on each screen




Material takes cues from contemporary architecture, road signs, pavement marking tape, and athletic courts. Color should be unexpected and vibrant.

This color palette comprises primary and accent colors that can be used for illustration or to develop your brand colors. They’ve been designed to work harmoniously with each other. The color palette starts with primary colors and fills in the spectrum to create a complete and usable palette for Android, Web, and iOS. Google suggests using the 500 colors as the primary colors in your app and the other colors as accents colors.

Themes enable consistent app styling through surface shades, shadow depth, and ink opacity.

orcanos software dashboard colors


Just so not everything is squeezed too much…lot of space is “lost” so user is not overwhelm with information

orcanos dashboard spaces


UI styling is based on CSS files rather than images to make Orcanos faster and robust


Every pixel counts…



Minimize number of icons, colors

orcanos software - icons


Define scrollable area so user remains on the same position always






Spacious list views, floating buttons

orcanos software - work items









Easily get your data using Orcanos tools:

Product tree, Search, Starred items list, Recent items list, Deleted item list


Dashboard panels


List views

orcanos software - work items

Easily navigate through work items path



If user prefers to have less spaces, he can easily switch from Comfortable mode to Cozy or Compact




All modules are accessible within one click

ALM (Product tree), Document Control (QMS), Service Center and e-sign (part 11)





Manage products, projects hierarchically, using Orcanos work items and traceability tool



Setup your FMEA Risk Management according your SOP within minutes



Orcanos service center to manage customer service calls, and trace them back to R&D or Quality Control



Hierarchic and intuitive Document Control, fully 21 CFR Part 11 compliant




Simple and powerful test management tool, as part of Orcanos ALM system




Creating projects, users, permissions and system settings and customization was never so easy





ORCANOS revamps user interface with a new Google Material Design experience

October 26th, 2016 Posted by Software Lifecycle Management 0 thoughts on “ORCANOS revamps user interface with a new Google Material Design experience”

ORCANOS revamps user interface with a new Google Material Design experience, to support its 2017 Adaptive ALM Platform

Rarely that a software company gets an opportunity to work on something that is a game changer. Something risky but meaningful. So we are now presenting for the first time Orcanos Adaptive ALM Platform.


ORCANOS is a leading provider in ALM and quality control, serving clients around the globe, and expertise in medical device. Understanding the particular needs of our customers is essential for a bootstrap organization, attempting to contend with huge ALM vendors.

So, for the question what do our clients need, we concluded that they need a modern, and clean user interface, and ONE STOP SHOP to manage their R&D/QA/RA activities.

ALM is one stop shop for R&D, but what about Quality? what about regulation? and how can one system manage everything in one place? and make it simple enough for the end user, that can be anyone from executive, developer, QA/RA or a tester?

And one more thing. There is no such thing as a generic, one-size ALM. Companies are different. testing, quality procedures and regulations requirements are different in each sector. This is why Orcanos came up with the Adaptive ALM platform.

It doesn’t matter if our customer is a 3 people startup developing the next medical device prototype in their garage, or a well established organisation, with well-established R&D department and quality procedures.

So after listening, studying, and getting all of the feedback, Orcanos put together a completely new ALM experience that is going to accelerate adoption of our users, submit to their industries or sectors. And we’re talking about a completely new user experience, not just colors and fonts tweaks.

Orcanos Adaptive ALM Cloud solution is available for evaluation and pilot starting January 2017, and is expected to be generally available in April 2017.

Orcanos Delivers Cloud Application Services on Windows Azure

June 28th, 2014 Posted by ALM 2.0, Company, Company News, Events 0 thoughts on “Orcanos Delivers Cloud Application Services on Windows Azure”


  • Orcanos Services to provide QPack ALM application services and workload solutions on the Windows Azure platform

  • Collaboration with Windows Azure design, delivery and management services for customers

Orcanos Services today announced that it will provide its customers a complete portfolio of services and solutions to enable development and management of applications lifecycle onto the Windows Azure platform. This collaboration expands Orcanos comprehensive suite of application services to include the leading cloud application platform from Microsoft.

Customers can now work with Orcanos as a single point of contact for design, delivery and ongoing management of applications lifecycle hosted in the cloud on Windows Azure. This will make it quicker and easier for them to adopt Windows Azure and drive benefits such as increased speed-to-market and agility, better collaboration across organizational boundaries, more modernized application portfolios and a greater ability to manage variable demand capacity needs.

With Windows Azure, Microsoft provides fully supported infrastructure and platform services offerings, spanning a comprehensive hybrid cloud solution that integrates existing IT infrastructure with the latest cloud technology.


Rami Azulay, vice president of sales and marketing and global head, Strategy and Business Innovation Services, Orcanos Services, said “This collaboration on Windows Azure is one of the many recent strategic efforts between Microsoft and Orcanos Services. Together, Orcanos and Microsoft will leverage the Windows Azure platform to deliver cloud application development services based on enterprise-class solutions powered by Microsoft technology.”

“Windows Azure helps customers use cloud technology in the way that best serves their unique needs,” said Zohar Peretz, CEO of Orcanos,. “We are excited to work with Microsoft Azure platform to help our customers take advantage of the flexibility, scalability and cost efficiencies afforded by Windows Azure.”


About Orcanos

Orcanos Ltd. listens to customers and delivers innovative technology and services that give them the power to do more. Orcanos Services develops and delivers a comprehensive suite of services and solutions in applications, business process, consulting, infrastructure and support to help customers succeed.

Orcanos is a trademark of Orcanos Ltd. Orcanos disclaims any proprietary interest in the marks and names of others.

Congratulations to Argo Medical: received FDA approval in the REWALK using QPack system to produce documents submission

June 28th, 2014 Posted by ALM 2.0, Company, Company News, Customers, FDA, IEC 62304, ISO 13485 0 thoughts on “Congratulations to Argo Medical: received FDA approval in the REWALK using QPack system to produce documents submission”

system allows paralyzed to stand and walk independently; Approval is expected to help the company realize its plans to go public or be sold at a high price

Argo Medical Corporation announced today (Friday) on receiving FDA approval for company’s REWALK system which allows paralyzed to go with it. Certification will be conducted with the help paralyzed in their homes, which until now have only been able rehabilitation centers. According to estimates, is expected to help the company realize certificate programs to its issuance, or alternatively to be sold at a high price. The submission process led the Israeli team in collaboration with the American team using Orcanos QPack medical manages the production of all documents, including changes in content in software validation documents along with Traceability tables automatically generated with non-contact person.

עמית גופר

Amit Goffer

Last March revealed “Kalkalist” Argo Medical intention to go public on NASDAQ at a value of $ 250 million – the value may even be higher if the company will issue shortly.

QPack Medical System is a system for managing development processes and quality for companies and manufacturers of Medical Equipment, containing the largest number of processes in one system integratively. Recently Orcanos released the seventh generation of the system and added two primary processes in Medical device product quality system. One document management system that includes electronic signatures subject to the conditions of 21 CFR Part 11 and the other, customer complaints management system in accordance with ISO 13485 section 4.2. These additions allows Orcanos SMB market also to handle the development of small firms in relation to changes in the process of quality. Also Orcanos added a new key component that enables us to work with external subcontractors and document changes QPack Web which saves time synchronization.

Download QPack cloud system:

Check out “QPack ALM

company, located in Yokneam, founded by Dr. Amit Goffer, four limbs paralyzed himself . The company, established in 2001, currently employs 50 employees in Israel and around the world. The system developed has received numerous awards and was shown at various events over the years, including President Barack Obama during his visit to the country.

Japanese Yaskawa Corporation (YASKAWA Electric) is considered a leading candidate to buy the company. Last year Argo Medical signed the strategic cooperation agreement with the corporation, which invested $ 10 million in the company, and signed her exclusive distribution agreement in Japan and China and the creation of customer service in Singapore, Thailand, Btayewan and South Korea. With investors include Life Sciences Fund also VitaLife Foundation, nitroprusside and Pontifax Fund.

According to reports, Argo has about 30 centers in the world who offer the system, and 200 who were trained to be assisted paralyzed her.

ReWalk is an exoskeleton suit that enables people with disabilities and lower limbs paralyzed stand and walk independently without assistance. Exoskeleton suit battery operated daily prolonged use, allowing the user convenience without having to recharge. ReWalk system is controlled by a computer and motion sensors, and controls movement through subtle changes in center of gravity, mimics natural gait and walking speed provides functional.

ברכות לארגו מדיקל: קיבלה אישור הרשות האמריקאית למערכת הריוואלק תוך שימוש במערכת קיופאק להפקת מסמכי ההגשה

June 28th, 2014 Posted by Software Lifecycle Management 0 thoughts on “ברכות לארגו מדיקל: קיבלה אישור הרשות האמריקאית למערכת הריוואלק תוך שימוש במערכת קיופאק להפקת מסמכי ההגשה”

ברכות לארגו מדיקל: קיבלה אישור ה-FDA למערכת ה-REWALK תוך שימוש במערכת QPack להפקת מסמכי ההגשה

המערכת מאפשרת למשותקים לעמוד וללכת עצמאית; האישור צפוי לעזור לחברה לממש את תוכניותיה לצאת להנפקה או להימכר במחיר גבוה

חברת ארגו מדיקל הודיעה היום (ו’) על קבלת אישור ה-FDA למערכת ה-REWALK של החברה המאפשרת למשותקים ללכת בעזרתה. האישור יאפשר למשותקים להתנהל בעזרתו בבתיהם, דבר שעד עכשיו התאפשר להם רק במרכזי שיקום. על פי הערכות, צפוי האישור לעזור לחברה לממש את תוכניות ההנפקה שלה או לחלופין להימכר במחיר גבוה. את תהליך ההגשה ניהל הצוות הישראלי בשיתוף עם הצוות האמריקאי כאשר מערכת QPack Medical של חברת אורקנוס מנהלת את הפקת כל מסמכי הוואלידאציה בהגשה הכוללים שינוים וטבלאות Traceability אוטומטים ללא מגע אדם.

עמית גופר

עמית גופר

במרץ האחרון חשף “כלכליסט” את כוונת ארגו מדיקל לצאת להנפקה בנאסדק לפי שווי של 250 מיליון דולר – שווי שייתכן שאף יהיה גבוה יותר אם תצא החברה להנפקה בקרוב.

מערכת QPack מדיקל הינה מערכת לניהול תהליכי פיתוח ואיכות לחברות ויצרנים של מכור רפואי היחידה בעולם המכילה את המספר הרב ביותר של תהליכים במערכת אחת איטגראטיבית.לאחרונה אורקנוס שיחררה את דור 7 של המערכת והוסיפה שני תהליכים מרכזים בחיי מוצר רפאוי. האחת מערכת לניהול מסמכים הכוללת חתימות אלקטרוניות בכפוף לתנאים של 21 CFR Part 11 והשניה מערכת לניהול תלונות לקוח בהתאם לתקן ISO 13485 פסקה 4.2. שני  תוספות אלה מאפשרות לאורקנוס לטפל גם בחברות קטנות מאד שהפיתוח ביחס לשינויים בתהליכי האיכות קטן יותר. כמו כן ארקנווס הוסיפה רכיב מרכזי חדש שמאפשר לנהל עבודה מול קבלני משנה חיצונים ושינויים במסמכי הוואלידאציה דבר שחוסך זמן סינכרון.


להורדת גרסאת ענן של המערכת:


Check out “QPack ALM


את החברה, הממוקמת ביקנעם, הקים ד”ר עמית גופר, משותק בעצמו בארבע גפיו. החברה, שהוקמה ב־2001, מעסיקה כיום כ־50 עובדים בישראל וברחבי העולם. המערכת שפיתחה זכתה בפרסים רבים והוצגה במהלך השנים באירועים שונים, לרבות בפני הנשיא ברק אובמה בעת ביקורו בארץ.

התאגיד היפני יאסקווה (YASKAWA Electric) נחשב למועמד מוביל לרכוש את החברה. בשנה שעברה חתמה ארגו מדיקל על הסכם שיתוף פעולה אסטרטגי עם התאגיד, שבמסגרתו השקיע כ־10 מיליון דולר בחברה, ואף חתם איתה על הסכם הפצה בלעדי ביפן ובסין ויצירת שירות לקוחות בסינגפור, בתאילנד, בטאייוואן ובדרום קוריאה. עם המשקיעים בחברה נמנים גם קרן מדעי החיים ויטהלייף, קרן פרוסיד וקרן פונטיפקס.

על פי דיווחיה, יש לה כ־30 מרכזים בעולם שכבר מציעים את המערכת, וכ־200 משותקים אשר אומנו להסתייע בה.

ReWalk, הוא חליפת שלד חיצונית המאפשרת לאנשים עם מוגבלויות גפיים תחתונות ולמשותקים לעמוד וללכת באופן עצמאי וללא עזרה. חליפת השלד החיצוני מופעלת באמצעות סוללות לשימוש ממושך ויומיומי, המאפשרות למשתמש נוחות ללא צורך בטעינה. מערכת ReWalk נשלטת על ידי מחשב וחיישני תנועה, ושולטת על התנועה באמצעות שינויים עדינים במרכז הכובד, מחקה הליכה טבעית ומעניקה מהירות הליכה פונקציונלית.

Orcanos Integrates QPack Instant Messaging Platform into QPack ALM System

June 26th, 2014 Posted by ALM 2.0, Company News, Services 0 thoughts on “Orcanos Integrates QPack Instant Messaging Platform into QPack ALM System”

TEL AVIV –(Business Wire)–Today Orcanos Ltd., developer of QPack ALM, the ALM medical system used by professional teams and companies worldwide, has released QPack messaging platform QPack.

This new capability unifies the communication of disparate teams and results in easier communication with automatic recording of all decisions, and customer interactions

QPack Instant messaging is designed to improve team performance by directly addressing its most important driver – team communication, as recent Researches shows that 50% of team performance improvement is attributable to the mode of communication. QPack Chat allows faster communication, combined with email notifications, and online invitation. QPack Chat contains the essential features needed, from group conferencing to shared work items, task management and custoemr complaints.

“Our vision has always been improving team communications along with professional toolsQPack instant messaging is a good example of our focus to drive business value to our customers,” said Zohar Peretz, CEO of Orcanos.


The QPack Chat is free to use for all users to access for an unlimited time

About Orcanos

Orcanos Ltd.. is the developer of QPack ALM and the QPack Chat, the conversation platform used by thousands of companies to plan, share and organize work. The result of more than 20 years of research and development in the area of real-time communication, QPack Chat is built with text and chat at its core and includes file sharing, collaborative task management, shared calendars, automatic version control, all integrated into each conversation stream, saving time and providing context for faster, better decisions. QPack ALM is designed to support teams of all sizes and flexible for working with large amounts of raw data in fast-paced environments. Be it application development teams, marketing teams or teams spread across continents, QPack Chat is the conversation platform that improves business while organizing it all for you.

"אורקנוס קפה" מפגש שלישי של קהילת יצרני ומפתחי המיכשור הרפואי

April 30th, 2014 Posted by Software Lifecycle Management 0 thoughts on “"אורקנוס קפה" מפגש שלישי של קהילת יצרני ומפתחי המיכשור הרפואי”
  • הם כבר באים … מה אתך?


    באירוח שלGE.jpg GE ובחסות Polaris



    בהמשך לפועלה בקהילת יצרני המיכשור הרפואי, אירועי “אורקנוס קפה” שמחים לארח למפגש שלישי את מר דוריין אברבוך ומר אלי גרינברג.

    המפגש מיועד ליזמים, מנהלי פיתוח ותפעול ,מנהלי בדיקות, למנהלי איכות וכמובן לחברי הנהלה המעוניינים לפגוש קולגות מהתעשייה, ללמוד מניסיון העבר על מנת ליישם ולהוביל תהליכי התייעלות במנגנוני האיכות באירגון.

    נושאי המפגש:

    • 5 טיפים בדרך לתהליך Agile Scrum בחברה רפואית.

    מר דוריין אברבוך ממציא, יזם ואיש תהליכים בעל למעלה מ – 20 שנות ניסיון, מגיע למפגש ב”אורקנוס קפה” ויעניק לקהל כלים יישומיים המאפשרים הנעת אירגון למעבר לתהליכי פיתוח בשיטת Agile Scrum. השיטה יושמה בהצלחה בחברות רפואיות ובפרויקטים מורכבים, תוך דגש על העלאת רמת מוכנות החברה לביקור אפשרי של ה-FDA ולביקורת CE ושימור דרישות הרגולציה והאיכות בתהליכי הפיתוח והייצור.

    • הקמת מערך אוטומציה לתהליך הפיתוח והייצור למוצרים רפואיים

    הרצאתו של מר אלי גרינברג מחברת Polaris. החברה עוסקת בפיתוח וייצור של מגוון פתרונות צב”ד לחברות ביטחוניות ורפואיות. הן עבור תהליכי פיתוח כגון Agile Scrum, הדורשים Continuous Build Cycle עם מנגנוני Verification & Validation מתועדים, והן עבור תהליכי ייצור Mass Production. פתרונותיה של חברת Polaris מתאימים לחברות קטנות וגדולות.

    בהרצאה נלמד מהם חמשת העקרונות העיקריים בבניה נכונה של צב”ד.

    תאריך המפגש: 02.06.2014 בשעה 16:00.

    מקום: משרדי חברת גיוון – GE, במרכז הפיתוח במת”מ שבחיפה.

    איך מגיעים: רח אתגר 4 טירת הכרמל, מפה.

    15:30 – 16:00

    התכנסות וכיבוד קל

    16:00 – 16:10

    דברי פתיחה של מנכ”ל אורקנוס זהר פרץ

    16:10 – 17:00

    הרצאה של מר דוריין אברבוך בנושא “איך מצליחים עם Agile Scrum והביא לשיפורי ביצועים בפיתוח”

    17:00 – 17:45

    הרצאה של מר אלי גרינברג מחברת Polaris בנושא “כללים לבניית ציוד בדיקה עבור תהליכי פיתוח וריצפת ייצור”

    17:45 – 18:00

    הפסקת קפה – Networkings

    18:00 – 18:30

    הרצאה של רמי אזולאי בנושא “סיכום פעילות תחום מיכשור רפואי בארץ ובעולם לשנת 2013 – 2014 וחידושים”

    18:30 – 18:45

    הגרלת זג כרטיסים להופעה של רולינג סטונס

    האירוע הינו ללא תשלום אך נדרש רישום מוקדם, מספר המקומות מוגבל.

    לרישום  לחץ כאן>>

    הפתעה !! בין באי הכנס יוגרל זוג כרטיסים להופעת להקת ה”רולינג סטונס” שיגיעו להופעה היסטורית בפארק הירקון ב-4 ביוני 2014.


Orcanos Cafe 3rd Event for Medical Device Development

April 27th, 2014 Posted by Company News, Orcanos Cafe, Software Lifecycle Management 0 thoughts on “Orcanos Cafe 3rd Event for Medical Device Development”

Orcanos cafe The 3rd Event on 02.06.2014


Hosted at General Electric GEUltrasound Division.


Orcanos café is planned to take place on 02.06.2014 at 16:00 – a meeting of the medical devices companies management members and developers discussing “How to get development satisfaction using Agile Scrum on Medical Device”. This event will also cover critical topic using ”ATE (Automation Testing Equipment) on Medical Device development and production line”

The meeting will be hosted by GE, at the regional development center area in Matam Ultrasound Division of GE.

As part of our continuous activities in the medical devices industry, and as part of our Orcanos Café meeting series, Orcanos is pleased to host Mr. Dorian Averbuch, one of the leading professionals in the field of software development for medical companies that successfully implemented Agile Scrum development methods for “Agile First Time Users” while maintaining REGULATORY & QUALITY requirements.

In addition, we will meet Mr. Eli Greenberg from Polaris Systems to highlight the topic on ATE (Automated Test Equipment) to be used both in production line and development stage. Eli is the founder of Polaris and comes with years of experience in the ATE domin. Eli will give 5 tips about how to build correctly your ATE equipment in order to reduce production cost and increase overall quality on the post marketing stage. Live demo and example will be given.


This meeting is intended for companies’ executive managers, entrepreneurs, VPs of development & operation, regulatory and quality managers, who wish to meet colleagues from the industry, and learn the lessons of the past in order to implement and lead their companies while streamlining the quality processes.


We welcome the participation of:

  • Medical Devices Start-ups & Manufacturing Companies.

  • Manager/ Engineers/Director/ VP of: Compliance ,Quality, Software Engineering, Research and Development, Product Development, Regulatory Affairs, C-Level Managers


Schedule for the day:

15:30- 16:00- Gathering, registration and refreshments.

16:00- 16:10- Opening speech by Zohar Peretz, CEO of Orcanos Israel.

16:10- 17:00- A lecture by Mr Dorian Averbuch

17:00- 17:45- A lecture by Eli Greenberg.

17:45- 18:00 – Networking Break with Coffee and Desert

18:00 – 18:30 – Orcanos 2014

18:30 – 18:45 – Lottery for Tickets to the Rolling Stones Live Concert

For more details please contact: Keren Meiri –

Please be advised, although the event is free of charge, early admission is required.

For admission press here

For Directions: 4 Etgar St. Tirat A Carmel map

Surprise!!! In honor of the new QPack 7.0 release, a lottery will be held, at the end of the event, and you can win 2 tickets to the Rolling Stones concert taking place on 04.06.2014.


Orcanos Café 2nd Event is hosted at Lumenis Company.

December 22nd, 2013 Posted by Company News, Events 0 thoughts on “Orcanos Café 2nd Event is hosted at Lumenis Company.”

 NOTE: All presentations can be requested from or

 Mike Zeevi Lecture: Orcanos Cafe – Recent Regulatory 2013 Updates (Presentation), The Video.

Hadas Mandel & Aaron Rothenberg Lecture: Mobile Health (Presentation), The video.

Orcanos Café is planned to take place on 26.12.2013 at 18:00 – a meeting of the medical devices companies management members and developers discussing “History and new requirements in software medical apparatuses, and the development of mobile “medical software

The meeting will be hosted by Lumenis, at the regional development center area in North Star Yokneam.

As part of our continuous activities in the medical devices industry, and as part of our Orcanos Café meeting series, Orcanos is pleased to host Mr. Mike Zeevi, one of the leading professionals in the field of software validation for companies submitting applications for medical equipment marketing approvals in the U.S. and EU markets, with emphasis on the level of companies readiness for possible FDA inspections.

In addition, we will start with a series of lectures for companies and entrepreneurs, seeking business development opportunities in new areas that will help build new anchors to the market they want to reach. The series of lectures will be presented by Aaron Rothenberg and Hadas Mandel from “Hitech Strategies” a consulting firm engaged in the process of strategic planning, business development, and fund raising for Life Sciences start-ups and companies.

The first lecture will focus on fund raising, from the point of view of investment funds and investors in the Life Sciences field, while focusing on the new and rising market field of Mobile Health. 5 useful tips for early stage ventures and companies seeking opportunity for business development in new areas in medical devices will be provided.

This meeting is intended for companies’ executive managers, entrepreneurs, VPs of development & operation, regulatory and quality managers, who wish to meet colleagues from the industry, and learn the lessons of the past in order to implement and lead their companies while streamlining the quality processes.

We welcome the participation of:

  • Medical Devices Start-ups & Manufacturing Companies.
  • Manager/ Engineers/Director/ VP of: Compliance ,Quality, Software Engineering, Research and Development, Product Development, Regulatory Affairs, C-Level Managers

Schedule for the day:

17:30- 18:00- Gathering, registration and refreshments.

18:00- 18:10- Opening speech by Zohar Peretz, CEO of Orcanos Israel.

18:10- 19:00- A lecture by Mr Mike Zeevi – Download Orcanos Cafe – Recent Regulatory 2013 Updates

19:00- 19:45- A lecture by Aaron Rothenberg and Hadas Mandel.

19:45- 20:00 – A tablet lottery, coffee break and networking

For more details please contact: Lee Green –

Please be advised, although the event is free of charge, early admission is required.


Surprise!!! In honor of the new year, a lottery will be held, at the end of the event, and you can win a tablet with the new

QPack Mobile app -M1 by Orcanos, who manages the product development process for medical equipment.

Orcanos Cafe

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Tel Aviv, Israel

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