QPack Medical Overview

April 22nd, 2013 Posted by Software Lifecycle Management 0 thoughts on “QPack Medical Overview”

QPack-Cortona3D Integration

April 22nd, 2013 Posted by Software Lifecycle Management 0 thoughts on “QPack-Cortona3D Integration”

10 tips for building quality award software

April 22nd, 2013 Posted by ALM 2.0 0 thoughts on “10 tips for building quality award software”

Golden Rules for Building Great Software

Building great software has always been a tough task, but it becomes even more complex today. True to Orcanos’ commitment to excellence in the field of ALM 2.0, we have been building our QPack solution and our company in the past five years in order to help you develop great software. We have been putting a lot of effort and paying meticulous attention to every step we take, while trying to innovate in our own field.

As a result of this hard work, you can now benefit from 10 points that will help an ALM project owner lead an organization through the complete Application Lifecycle Management solution. This method has also been our own decisive success factor.

So here are ten golden rules for building great software:

1. Gain Management Skills: You can learn most of the skills needed in order to be a good manager. The management skills required include proper planning, execution and follow ups on tasks. Selection of the right steering team is also part of the management skills you need, as you will be required to empower your team to complete their tasks without your attention.

2. Have an Executive Sponsor: An executive sponsor is an executive manager who owns the ALM project in your organization but is also the one who pays the bills. Attendees who act as executive sponsors at kickoff meetings demonstrate management support for both the project leader and the ALM effort. The executive sponsor has the authority to resolve impasses that occur during the implementation project

3. Invite the Right People: Make sure all the right people attend the initial meetings. Overloading those meetings with a mix of people may create early conflicts while the first stage is all about brainstorming and rethinking your existing status. Bring subject matter experts whose advice is valuable for the discussions, as well as those individuals whose approval is mandatory in the decision making process. Make sure that decision makers not only have the authority to make decisions but also have the will to do so.

4. Assign People to Roles: Every person in the steering team is assigned to a specific role. In addition to the ALM project leader who plans and conducts the steering meetings, there is the executive sponsor, and a scribe who records decisions and unresolved issues. The ALM project owner should make sure each one of these individuals understands and plays his or her assigned role.

5. Do the Mandatory Pre-Work: It is important for the ALM project owner to ensure that everyone does the pre work prior to the actual Go-Live stage. Evaluating the solution according to pre defined success criteria is critical in order to shorten the evaluation stage. Learn yourselves first and identify the most critical issues you want to resolve. Make sure there is enough time for all the members of the steering team to review the material they need to respond to. Make sure you get feedback on critical issues first and then on the rest. Contact your steering team members periodically to make sure all decision makers are communicating well with each other.

6. Consider Pre-Meetings: For those who are new to the ALM world or to leading such a project, the ALM project owners should conduct a short training session prior to the first meeting. This will help the steering team understand the benefits of the ALM solution, the importance of the pre-work, the roles and the rules, the meeting processes and the consensus approach to decision making.

7. Obey the Rules: To ensure an orderly conduct of an ALM project, certain ground rules need to be in place. These rules are non negotiable and should be reviewed with the steering team before starting the evaluation of the ALM solution. Some of the standard ground rules are: Stick to the agenda; Discuss one topic at a time; Stop the project meetings in case a key participant leaves or is not attending; All decisions are either “yes” or “no”; Be open to all ideas; Treat all the decision makers as equal.

8. Go for Consensus: Decisions should be consensus-driven and simply be put to a vote. ALM projects involve all stakeholders in the organization, so leaving an important stakeholder out could disrupt the necessary information flow. Consensus-based decisions require participants to prefer the overall interests of the organization over individual interests. Consensus means decisions are supported both during the evaluation and after Go-Live.

9. Ensure Mutual Respect: It is important that ALM implementation will be conducted in an atmosphere of fairness and mutual respect. It is the ALM project owner’s duty to ensure that ideas and work products – rather than a specific stakeholder – are addressed in the final ALM solution. After all, ALM is an organizational platform and should be treated as such.

10. Get the Signoff: It is important that the ALM project owner will present the final deliverables (e.g. Reports, Design Documents, Plans, etc.) to the primary participants, in order to get their formal signoff. This assures the stakeholders fully accept the decisions taken and agree to move forward.

Orcanos 2013 Medical Device Industry Event

February 25th, 2013 Posted by Events 0 thoughts on “Orcanos 2013 Medical Device Industry Event”

 

הכנס השנתי השישי לניהול תהליכי פיתוח במכשור רפואי 7.5.13 במלון השרון בהרצליה
07/05/2013
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שיטות ודרכים להתמודדות עם רגולציה ותקנים בפיתוח מכשור רפואיאנו שמחים להודיע על קיומו של הכנס השנתי השישי של מקיט ואורקנוס, אשר יתקיים בתאריך ה-7 במאי 2013 במלון השרון, הרצליה.

בכנס זה תוכלו לפגוש את מובילי השוק בתעשיית המכשור הרפואי, וללמוד מחוויית הלקוח על שימוש בטכנולוגיות חדשניות לניהול תהליכי פיתוח רגולטוריים.
בכנס ישתתפו מיטב יצרני המכשור הרפואי בארץ ובעולם, וכן מומחים השותפים בוועדות התקינה שיציגו את העידכונים האחרונים בתקנים IEC-62304, IEC-60601, IEC-62366, ISO-14971, עקיבות (Traceability) בתיק ההגשה (DHF) ודרכים ליישום הלכה למעשה באירגונכם.השנה נארח את מר שרמן איגלס, מומחה בעל שם עולמי בתחום ניהול מחזור חיי תוכנה במכשור רפואי בחברות מובילות בארה”ב ובעולם.
כמו כן השנה ינתן דגש על תהליך פיתוח Agile Scrum לחברות רפואיות ע”י סיפור לקוח מחברת Given Imaging.

מוזמנים להגיע:

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

על סדר היום:
 09:00  08:15 התכנסות,  רישום וארוחת בוקר קלה
 09:10  09:00 דברי פתיחה
זוהר פרץ, מנכ”ל אורקנוס ישראל
 09:50  09:10 IEC 62304  – עשרה דברים שעליך לדעת על העדכון לתקן במהדורה II
עדכונים בנושא ניהול מחזור חיי תוכנה בציוד רפואי
שרמן איגלס
 10:30  09:50 סיפור לקוח – חברת מזור – עבודה עם מסמכים חכמים
איך עבודה עם מסמכים חכמים דרך מערכת Qpack Medical  תחסוך לכם 30% מעלויות התיפעול
יעל סירפד, מזור
 11:00  10:30 הפסקת קפה ו- Netoworking
 11:40  11:00 יישום מתודולוגית SCRUM  בחברות מכשור רפואי
Taking Scrum to the Next Level: From a Generation Based Product to a Brand New One
חגי לבני, מנהל תחום ואלידציה, Given Imaging
 12:20  11:40 פאנל מקצועי בנושא אסטרטגיות יישומיות למלחמה ב- RECALL
בהשתתפות:
רמי בן ארי, אופיר קורן (סמנכ”ל פיתוח ארגו), אורן תמרי (סמנכ”ל תפעול ארגו), אלי זהבי (סמנכ”ל תפעול מזור), דוקטור אברהם לזרי (מנהל החטיבה לנפגעי מוח ברעות – מרכז רפואי שיקומי), שרית גלברט (יועצת בתחום הרגולציה), אלון בלנקשטיין (Partners500)
 13:00  12:20 תערוכה ו- Netoworking
 14:00  13:00 ארוחת צהריים
השנה יוגרלו זוג כרטיסים להופעה של דפש מוד בארץ, שתתקיים ביום הכנס, ב- 07.05.2013 !
בין 100 המשתתפים הראשונים שיגיעו לכנס יוגרלו זוג כרטיסיGolden Ring משודרגים באיזור הבמה !לפרטים על ההופעה לחץ כאן >>

ההכרזה על הזוכה תבוצע במהלך הכנס.

מחכים לראותכם בכנס !

* תנאי ההגרלה:

  • על הזוכה להיות נוכח בכנס, במידה והזוכה לא יהיה נוכח, תתבצע הגרלה חוזרת.
  • הגרלה זו אינה מיועדת לעובדי אורקנוס ומקיט ובני משפחותיהם.
  • אורקנוס שומרת לעצמה את הזכות לשנות את תנאי ההגרלה כראות עיניה.
להדפסת ההזמנה לחץ כאןלפרטים נוספים : מוריה דסקלו: moriyad@mckit.co.il , קרן המאירי: kerenm@orcanos.com
רשמים של משתתפים מהכנס הקודם:

סוהיר פרנסיס נג’ר, מנהלת אבטחת איכות, Invasix:

 “I had the chance to participate in the 5th annual summit for medical device of Orcanos and Mckit, and I must say it was a very professional event, the team has made an amazing job building a very interesting plan and interesting customer stories”.

 אורן תמרי, סמנכ”ל תפעול, Argo Medical:

 “תודה על ההזדמנות להציג, בכנס ליצרני ציוד רפואי שנערך בשנה שעברה ע”י חברת אורקנוס ומקיט את אופן העבודה בחברת ארגו טכנולוגיות רפואיות, ולראות לקוחות נוספים בתחום שמתמודדים עם אתגרים דומים לשלנו. הכנס היה מקצועי וברמה גבוהה מאוד”.

 שני אנתבי, מנהלת ומיישמת מערכת QPack בחברת Given imaging :
 “ברכותיי על אירוע איכותי. נהניתי מאוד מהדגש על נקודת המבט של המשתמש ולמדתי הרבה מלקוחות דומים לנו שהטמיעו את מערכת QPack”.
 צבי אפל, מנהל ולידציה, Integrity Application Ltd:
 “זו הייתה חוויה מעניינת, אף על פי שהיתה לי חשיפה לפתרונות ולספקים בעבר, יצא לי לראות אנשים המתמודדים עם אתגרים של העולם האמיתי בתחום הרפואי ולמדתי הרבה”.
 רני חורב, מנהל פרוייקטים, Lumenis:
“בהחלט הכנס השנתי שלכם היה מאוד מקצועי ומעניין, אני נהנה לבוא כל שנה וללמוד דברים חדשים, תמיד אתם מצליחים להפתיע, ואשמח להגיע גם השנה”.

 דינה ספרי, מנכ”ל Med-Dev Design:

 “כמו בכל שנה, הכנס השנתי החמישי של אורקנוס ומקיט היה מקצועי ומעניין מאוד. אני מודה על ההזדמנות שניתנה לי להרצות בכנס ולתרום למשתתפים מהידע והניסיון שלי בתחום פיתוח מערכות רפואיות”.

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ALM 2.0 Methodologies for Software Companies

February 18th, 2013 Posted by Software Lifecycle Management 0 thoughts on “ALM 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 company is going through and the reasons for doing so.

Course duration 30 academic hours divided into 10 sessions of 3 hours.

QPack ALM Requirements Management And Doors Integration

November 16th, 2012 Posted by Requirements Management Tool 0 thoughts on “QPack ALM Requirements Management And Doors Integration”

QPack Medical Webinar, October 2012

November 11th, 2012 Posted by IEC 62304, ISO 13485, ISO 14971, Requirements Management, Risk Management, Software Lifecycle Management, Test Management, Validation and Verification 0 thoughts on “QPack Medical Webinar, October 2012”

QPack ALM and Teamcenter PLM Integration

November 11th, 2012 Posted by Requirements Management Tool 0 thoughts on “QPack ALM and Teamcenter PLM Integration”

QPack Risk Form According to ISO14971

October 23rd, 2012 Posted by IEC60601, ISO 14971, Risk Management 0 thoughts on “QPack 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

  1. Describe the hazard
  2. Select risk category
  3. Define the feature/function hazard relates to
  4. Describe Potential harm
  5. Describe Cause of failure

4.4. Risk Estimation

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The risk level (RPN=Risk Priority Number) is automatically calculated

5. Risk Evaluation

Decide whether risk should be controlled by the predefined acceptability zone (Acceptable, ALARP, Unacceptable)

6. Risk Control

6.2 Risk Control Measures

Define control type

6.4 Final Risk Evaluation – Residual Risk

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The residual risk level (RPN=Risk Priority Number) is automatically calculated

6.6. New Hazard

A new   hazard created? (yes/no)

7. Verification and validation

Evaluation of overall residual risk acceptability

Use QPack traceability to relate artifacts used for risk control.

The test cases (verification) should be connected to design artifacts to assure verification

Risk management terminology and characteristics

August 30th, 2012 Posted by IEC 62304, IEC60601, ISO 14971, Risk Management, Standards and Regulations 0 thoughts on “Risk 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 the Probability of occurrence of Harm and its Severity
  • Risk control/ Risk mitigation: the means taken to reduce the risk
  • Residual risk: Remaining risk after risk control measures have been implemented

So, Hazard creates the risk that can cause harm: what can go wrong, what is the likelihood for this to happen, what would be the consequences and is the risk level tolerable or not?

Example 1 : Risk analysis to mobile phone: The radiation (hazard) that caused because of crack in mobile phone body (failure cause) causes severe headaches (harm) solved by using materials according to relevant standards (risk control)

Type of optional hazards – hazard category (partial list)

  • Energy
  • Biological
  • Chemical
  • Environmental
  • Hazards Related to the Use of the Device
  • Functional Failure
  • Maintenance
  • Aging
  • more…

Risk probability/frequency values (the probability for the harm to occur)

  • Improbable (So unlikely, it can be assumed occurrence may not be experienced)
  • Remote (Unlikely, but possible to occur in life of an item)
  • Occasional (Likely to occur sometime in life of an item)
  • Probable (Will occur several times in life of an item)
  • Frequent (Likely to occur frequently)

Risk severity values (the severity of the harm!!)

  • Negligible
  • Minor
  • Moderate
  • Major
  • Catastrophic

Risk control types

  • Safety by design
  • Protective measures – in the medical devices itself or in the manufacturing process – alarms, production line tests
  • Information for safety – marking, user manual
  • Operational – Workshops, training courses…

Risk properties

  • Hazard – what can go wrong
  • Category – see list above
  • Failure cause – what cause the hazard
  • Condition – Normal use, single fault, incorrect use
  • Affected – Patient, operator, service personal, bystanders, environment
  • Probability1 (also known as occurance/likelyhood/Frequency) – probability of the harm before risk control
  • Severity1 – severity of the harm before mitigation
  • RPN1 (risk level1) – the risk estimation result (Severity and probability) before mitigation
  • Control type – see above
  • Reduction necessary? – yes/no for hazards that are in ALARP zone
  • Probability 2 – after mitigation (risk control)
  • Severity 2 (not always in use, usually equal to Severity1)
  • RPN 2 – after mitigation
  • New hazard created – yes/no. Indicates if new risks arises from risk control
  • Related artifacts (for control) – relations to SRS, HRS, user manual…
  • Status – risk status, see in our blog some examples (hazard identification->risk estimation risk control identification->risk control implementation->verified)
  • Verification type – external labs, test management, training (you can use a descriptive field as well)
  • Verification description
  • Applicable component
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