Iso 14971

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Free Webinar ISO 14971:2012

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Duration: 25:37
Updated: 27 May 2013

http://wn.com/Free_Webinar_ISO_149712012

Proper Documentation of Risk Management for Compliance with ISO 14971

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Duration: 15:00
Updated: 18 Dec 2012

Areas Covered in the Session: * Exploring the Risk Management tool set * Choosing the right risk management tools * What tools are used during each phase of ...

http://wn.com/Proper_Documentation_of_Risk_Management_for_Compliance_with_ISO_14971

Risk management for medical devices - ISO 14971

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Duration: 5:32
Updated: 03 Jun 2013

See a one hour FREE course on the same topic on www.gantus.com/iso14971. A short introduction to risk management for medical devices according to ISO 14971.

http://wn.com/Risk_management_for_medical_devices_ISO_14971

Risk analysis according to ISO 14971

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Duration: 13:33
Updated: 18 Mar 2013

This is a screen recording of a web-based course on risk management and ISO 14971. A full course on risk management and ISO 14971 is available at t http://ww...

http://wn.com/Risk_analysis_according_to_ISO_14971

Leveraging Traceability in Your Risk Management Strategy

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Duration: 34:09
Updated: 13 Aug 2013

Identifying, managing, mitigating, analyzing, and tracing risk is recommended for medical device development by ISO 14971 and the FDA. Watch this webinar rec...

http://wn.com/Leveraging_Traceability_in_Your_Risk_Management_Strategy

Risk management for medical devices and ISO 14971, e-learning

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Duration: 1:55
Updated: 04 May 2012

Web-based, on-demand course on risk management for medical devices and ISO 14971.

http://wn.com/Risk_management_for_medical_devices_and_ISO_14971,_e-learning

Testimonial: Medical Device Risk Management (ISO 14971) & Safety Assurance Case Software

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Duration: 2:47
Updated: 26 Dec 2013

Dr. Andrei Yosef, VP of Q Core Medical, sharing their experience with GessNet TurboAC ISO 14971 Medical Device Risk Management and Safety Assurance Case Software Solutions: all in one tool for medical device risk management and safety assurance case: streamline, automate, integrate medical device risk management activities and results; automatically generate safety assurance case for FDA submission. More information is available at http://www.gessnet.com

http://wn.com/Testimonial_Medical_Device_Risk_Management_ISO_14971_Safety_Assurance_Case_Software

ISO 14971 konformes Risikomanagement [Polarion Webinars]

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Duration: 4:56
Updated: 05 Dec 2013

Full recording: http://www.polarion.com/company/events/webinarondemand.php?wod=ISO-14971-konformes-Risikomanagement Visit http://www.polarion.com for more information.

http://wn.com/ISO_14971_konformes_Risikomanagement_Polarion_Webinars_

Medicinteknik ISO 14971

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Duration: 3:19
Updated: 04 May 2012

Programstöd för ISO 14971. Framtagen av Makeitec AB.

http://wn.com/Medicinteknik_ISO_14971

Applying Risk Management concepts to Medical Device Software

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Duration: 54:44
Updated: 24 Jun 2013

This webinar gives an introduction to Use of Risk Management Process for building software to be used in medical devices. The only international standard for...

http://wn.com/Applying_Risk_Management_concepts_to_Medical_Device_Software

E-Learning zur IEC 62304, ISO 14971, IEC 62366 und Entwicklung medizinischer Software und mehr

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Duration: 3:15
Updated: 22 Feb 2013

Der Institutsclub bietet leicht verständliche und unterhaltsame E-Learning-Einheiten zur normenkonformen Entwicklung medizinischer Software und aktiver Mediz...

http://wn.com/E-Learning_zur_IEC_62304,_ISO_14971,_IEC_62366_und_Entwicklung_medizinischer_Software_und_mehr

Risk Management - Motorized Bariatric Mat Table - ISO 14971

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Duration: 2:29
Updated: 30 Oct 2013

Demonstration of risk management safety features with regard to the Tri W-G Motorized Bariatric Mat Table and compliance with ISO 14971. Featuring 1000 LB weight capacity and pinch factors.

http://wn.com/Risk_Management_Motorized_Bariatric_Mat_Table_ISO_14971

101 14971]

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Duration: 0:02
Updated: 16 Aug 2013

http://wn.com/101_14971_

ISO 13485 Overview Training video

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Duration: 13:01
Updated: 13 Aug 2013

FREE ISO 13485 Overview training for medical devices. Full course available at: http://www.caliso9000.com/iso_13485_lead_auditor.html Join our Blog at: http:...

http://wn.com/ISO_13485_Overview_Training_video

Medical Device Standards, Part 2: Risk

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Duration: 7:41
Updated: 03 Dec 2012

A brief introduction to addressing risk in medical devices. Topics addressed include: - How do medical device standards incorporate risk? - What are general ...

http://wn.com/Medical_Device_Standards,_Part_2_Risk

Part 6: Medical Devices Regulatory Harmonization Training Program: ASEAN-Wide Training

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Duration: 45:26
Updated: 27 Sep 2013

Session 5: Risk Management and ISO 14971 ใน session นี้ วิทยากรจะพูดเกี่ยวกับระบบบริหารจัดการความเสี่ยงของเครื่องมือและอุปกณ์ทางการแพทย์ (ISO14971) ในวันที่ 21-22 สิงหาคม พ.ศ. 2556 ฝ่ายการพาณิชย์สถานทูตสหรัฐอเมริการ่วมมือกับสำนักงานคณะกรรมการอาหารและยา(อย.) กระทรวงสาธารณสุข องค์กรเพื่อการพัฒนาระหว่างประเทศของสหรัฐ หรือ USAID สมาคม Advanced Medical Technology Association ของสหรัฐ และสำนักเลขาธิการอาเซียน ในการจัดงานฝึกอบรมเพื่อให้ความรู้ในเรื่อง Medical Devices Regulatory Harmonization Training Program: ASEAN-Wide Training เนื่องจากภายในปี พ.ศ. 2558 ประชาคมอาเซียน มีแผนที่จะใช้กฎระเบียบด้านเครื่องมือแพทย์เดียวกัน ที่เรียกว่า ASEAN Medical Device Directive (AMDD) ซึ่งครอบคลุมถึง การวางกฎข้อบังคับเดียวกันในเรื่องความปลอดภัยและประสิทธิภาพของเครื่องมือแพทย์ การจัดกลุ่มประเภทเครื่องมือแพทย์ ชุดเอกสารสำหรับใช้จดทะเบียนเครื่องมือแพทย์ หรือที่เรียกว่า Common Submission Dossier Template (CSDT) และระบบเตือนเรื่องความปลอดภัยในการใช้งานของเครื่องมือแพทย์หลังการวางจำหน่าย ท่านสอบถามรายละเอียดเพิ่มเติมได้ที่คุณกรลักษณ์ ฝ่ายพาณิชย์ สถานทูตสหรัฐ โทร 02-20552

http://wn.com/Part_6_Medical_Devices_Regulatory_Harmonization_Training_Program_ASEAN-Wide_Training

Mitigating and Managing Risk for Medical Device Product Development [Polarion Webinars]

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Duration: 6:29
Updated: 13 Aug 2013

Full recorded webinar at http://www.polarion.com/company/events/webinarondemand.php?title=Mitigating+and+Managing+Risk+for+Medical+Device+Product+Development...

http://wn.com/Mitigating_and_Managing_Risk_for_Medical_Device_Product_Development_Polarion_Webinars_

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Duration: 2:06
Updated: 03 Nov 2013

ISO 13485:2003 Medical Devices Management System

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Duration: 0:57
Updated: 23 Aug 2013

http://www.cgbusinessconsulting.com - 1SO 13485:2003 is an internationally recognized standard that sets out requirements for a comprehensive management system for the design, development, manufacture, installation and servicing of medical devices.

http://wn.com/ISO_134852003_Medical_Devices_Management_System

Risk Control Measures in Medical Device Development

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Duration: 4:51
Updated: 09 May 2013

Listen as Dr. David Vogel of Intertech Engineering discusses the different levels of risk controls available to medical device development teams during the p...

http://wn.com/Risk_Control_Measures_in_Medical_Device_Development

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Duration: 1:48
Updated: 02 Nov 2013

Cook Medical: Always Do the Right Thing

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Duration: 3:01
Updated: 29 Mar 2012

Cook Medical takes patient safety seriously - find out why they chose Crimson Life Sciences to translate their product labeling. Crimson is the only translat...

http://wn.com/Cook_Medical_Always_Do_the_Right_Thing

Cost-Saving Technology Solutions from TransPerfect/Crimson

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Duration: 3:33
Updated: 04 May 2012

Combining patented, ISO 14971-certified risk management with advanced technology to deliver cost savings and lower risk to medical device manufacturers.

http://wn.com/Cost-Saving_Technology_Solutions_from_TransPerfect_Crimson

photo: AP / Sang Tan

Arsenal's Olivier Giroud plays against Chelsea during their English Premier League soccer match at Stamford Bridge, London, Sunday, Jan. 20, 2013.

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Arsenal striker Olivier Giroud apologises for affair with lingerie model

Sydney Morning Herald

16 Feb 2014

Arsenal's French striker Olivier Giroud has issued an apology after a British tabloid newspaper alleged that he had an extra-marital affair....(size: 0.6Kb)

photo: AP / Sunday Alamba

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Over 100 killed in Islamist attack in Nigeria: Senator

The Times of India

17 Feb 2014

KANO, Nigeria. Suspected Boko Haram Islamists have killed more than 100 people in an attack on a village in Nigeria, a local senator said. The attackers stormed the village in Nigeria's restive northeastern Borno state on Saturday, slaughtering scores of civilians and sending many others fleeing ... ....(size: 1.4Kb)

photo: AP / Sergey Ponomarev

File - Russian army Topol ballistic missile on a mobile rocket launcher make its way down a road during a rehearsal for the Victory Day military parade which will take place at Moscow's Red Square on May 9 in central Moscow, Russia, late Tuesday, May 3, 2011.

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Moscow's struggle to protect nuclear material

Al Jazeera

18 Feb 2014

- More than two decades after the collapse of the Soviet Union, the planet's largest stockpile of nuclear weapons materials remains insecure, according to a series of US intelligence reports obtained by Al Jazeera's Investigative Unit ... "We judge it highly unlikely that Russian authorities have been able to recover all of the stolen material." ... Nuclear operations were temporarily shut down ... "A key question is ... View the reports below. ... ....(size: 6.9Kb)

photo: WN / Bhaskar Mallick

Bollywood Actress Vidya Balan during the inauguration of Palki Boutique in Kolkata on Wednesday 05 February 2014

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Vidya Balan says NO to green tea

The Times of India

17 Feb 2014

Vidya Balan comes across as a very natural and real person and that makes her very lovable. Unaffected by the mad race around, Vidya is a woman comfortable in her skin who believes in making her own road and not following the one which already exists ... "Most people have heard me say this that I lost my bearings for a while because I was trying desperately to fit in ... ....(size: 1.7Kb)

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FCPA Enforcement Broadens in 2013: Key Concerns for All Companies

PR Newswire

13 Feb 2014

Download image. Translation Services - Merrill Brink. (PRNewsFoto/Merrill Brink International). NEW YORK, Feb. 13, 2014 /PRNewswire-iReach/ -- The U.S. government's enforcement of the U.S ... (Photo. http.//photos.prnewswire.com/prnh/20140213/MN64683) ... Settlement costs have drastically increased ... References ... 2 ... Merrill Brink is certified to ISO 9001.2008; ISO/IEC 27001.2005 and ISO 13485.2003, and compliant to EN 15038.2006 and ISO 14971.2007 ... ....(size: 6.2Kb)

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Creation Technologies Gains Sixth FDA-Registered Manufacturing Facility (Creation Technologies LP)

noodls

05 Dec 2013

(Source. Creation Technologies LP) News. Release ... News Release ... "FDA registration is a key supplement to the ISO 13485 certiﬁcation we have in 12 of our business units, including here in Milwaukee," said Dan Dery, General Manager ... The two locations operate together as Creation Design Services and specialize in providing full design & development services to Creation's medical and other OEMs, and are both ISO 14971 and ISO 13485-certiﬁed ... ....(size: 4.5Kb)

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Noser Engineering AG Expand Medical Device Technology Offering Meeting the Needs of Global Regulatory Compliance and Accelerating Time to Market

PR Newswire

19 Nov 2013

Download image. Noser Engineering AG Logo. WINTERTHUR, Switzerland, November 19, 2013 /PRNewswire/ -- ... (Logo. http.//photos.prnewswire.com/prnh/20121129/579904 ) ... said Dr ... Project Management, Quality Management and Risk Management are executed applying V-Modell and SCRUM for project management, ISO 13485 for quality management, and ISO 14971 in support of risk management with FMEA, PHA or FTA ... Contact . ... Tel. ... ....(size: 3.7Kb)

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Major Changes in Medical Device CE Certification start in 2014 (SGS SA)

noodls

14 Oct 2013

Manufacturers should be aware that ISO 14971 alone is not sufficient and the EU regulatory requirements of reducing risks 'as far as possible' and applying safety principles 'compatible with the state-of-the-art' must also be incorporated into the risk management process ... on the EU view of risk (as also clarified in Annex Z of EN ISO 14971.2012)....(size: 16.2Kb)

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FDAnews Announces Medical Device Risk Management Conference, Nov. 5-6, Chicago, IL

PR Newswire

02 Oct 2013

ETA, FTA, HACCP, PHA, HAZOP -- The New Tools for Effective Device Risk Management. Download image. FDANews and Ombu Enterprises Present. Medical Device Risk Management Workshop. (PRNewsFoto/FDAnews). FALLS CHURCH, Va., Oct. 2, 2013 /PRNewswire-iReach/ -- ... Nov ... And as a bonus; this tightly focused workshop, will explain 4 new standards that call out ISO 14971 and how they can be integrated into your program. The new standards include ... ....(size: 5.3Kb)

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Merrill Brink International Forms Strategic Partnership with FCPAmericas

San Francisco Chronicle

11 Sep 2013

Merrill Brink International (http.//www.merrillbrink.com), is pleased to announce a strategic partnership agreement with FCPAméricas to translate its web content. St. Paul, MN (PRWEB) September 10, 2013 ... “Bribery occurs in all languages ... Compliance must be conducted in local languages ... Merrill Brink is certified to ISO 9001.2008; ISO 27001.2005 and ISO 13485.2003, and registered to EN 15038.2006 and ISO 14971.2007....(size: 4.3Kb)

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>Merrill Brink International Forms Strategic Partnership with FCPAmericas

Seattle Post

11 Sep 2013

Merrill Brink® International, a leading global provider of language solutions for global companies and law firms, announced a strategic partnership agreement with FCPAméricas to provide translations of articles for the FCPAméricas website content. London, UK (PRWEB UK) 11 September 2013 ... Merrill Brink is certified to ISO 9001.2008; ISO 27001.2005 and ISO 13485.2003, and registered to EN 15038.2006 and ISO 14971.2007....(size: 4.5Kb)

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Merrill Brink News Reviews and Opinion: The Contributors and Authorities Role to Facilitate a Smooth ...

San Francisco Chronicle

24 Aug 2013

http.//www.merrillbrink.com -- The three main contributors and authorities in pharmacovigilance are the industry, payors and competent authority. New York, US (PRWEB) August 23, 2013. Click here to read the full article ... Read the full article here ... About Merrill Brink International ... Merrill Brink is certified to ISO 9001.2008; ISO 27001.2005 and ISO 13485.2003, and registered to EN 15038.2006 and ISO 14971.2007....(size: 4.0Kb)

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>Merrill Brink News Reviews and Opinion: The Contributors and Authorities Role to Facilitate a Smooth ...

Seattle Post

24 Aug 2013

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Merrill Brink News Reviews and Opinion: The Contributors and Authorities Role to Facilitate a Smooth and Efficient Pharmacovigilance Process

Houston Chronicle

24 Aug 2013

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Merrill Brink International Releases White Paper "Pharmacovigilance: Five Keys To Language Transparency and Optimized Reporting"

Houston Chronicle

20 Aug 2013

http.//www.merrillbrink.com -- Merrill Brink International, a leading global provider of language solutions for global companies and law firms, today announced that it has published a new white paper, “Pharmacovigilance. Five keys to language transparency and optimized reporting.”. St ... Full Text ... Merrill Brink is certified to ISO 9001.2008; ISO 27001.2005 and ISO 13485.2003, and registered to EN 15038.2006 and ISO 14971.2007....(size: 3.7Kb)

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>Merrill Brink International Releases White Paper "Pharmacovigilance: Five Keys To Language Transparency and Optimized Reporting"

Seattle Post

20 Aug 2013

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Research and Markets: Medical Device Software Regulations and Requirements - New Meeting (Course, London)

Business Wire

02 Jul 2013

“Medical Device Software Regulations and Requirements - New meeting (Course, London)” ... PROGRAMME TO INCLUDE. - MDD 93/42/EEC - Implications for Software . - Overview of Relevant Standards ... - Risk Management ISO 14971 ... - Hospitals, Networks and ISO 80001 Standards ... A Certificate for ISO 14971, IEC 62304 and Risk Management will be given to each delegate on successful completion of a Risk Management Understanding test ... Dates....(size: 5.5Kb)

This page contains text from Wikipedia, the Free Encyclopedia - http://en.wikipedia.org/wiki/ISO_14971

This article is licensed under the Creative Commons Attribution-ShareAlike 3.0 Unported License, which means that you can copy and modify it as long as the entire work (including additions) remains under this license.

Free Webinar ISO 14971:2012

Proper Documentation of Risk Management for Compliance with ISO 14971

Risk management for medical devices - ISO 14971

Risk analysis according to ISO 14971

Leveraging Traceability in Your Risk Management Strategy

Risk management for medical devices and ISO 14971, e-learning

Testimonial: Medical Device Risk Management (ISO 14971) & Safety Assurance Case Software

ISO 14971 konformes Risikomanagement [Polarion Webinars]

Medicinteknik ISO 14971

Applying Risk Management concepts to Medical Device Software

E-Learning zur IEC 62304, ISO 14971, IEC 62366 und Entwicklung medizinischer Software und mehr

Risk Management - Motorized Bariatric Mat Table - ISO 14971

101 14971]

ISO 13485 Overview Training video

Make changes yourself !

Free Webinar ISO 14971:2012

Proper Documentation of Risk Management for Compliance with ISO 14971

Risk management for medical devices - ISO 14971

Risk analysis according to ISO 14971

Leveraging Traceability in Your Risk Management Strategy

Risk management for medical devices and ISO 14971, e-learning

Testimonial: Medical Device Risk Management (ISO 14971) & Safety Assurance Case Software

ISO 14971 konformes Risikomanagement [Polarion Webinars]

Medicinteknik ISO 14971

Applying Risk Management concepts to Medical Device Software

E-Learning zur IEC 62304, ISO 14971, IEC 62366 und Entwicklung medizinischer Software und mehr

Risk Management - Motorized Bariatric Mat Table - ISO 14971

101 14971]

ISO 13485 Overview Training video

Medical Device Standards, Part 2: Risk

Part 6: Medical Devices Regulatory Harmonization Training Program: ASEAN-Wide Training

Mitigating and Managing Risk for Medical Device Product Development [Polarion Webinars]

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