2015 calendar

2 015 CALENDAR

Active nerve cell in human neural systemwww.aami.org

Tuesday Wednesday Thursday Friday Saturday

January 2015

Nelson Laboratories, [email protected]

Nelson Laboratories believes in The Science of SuccessTM. It’s knowing that every test matters and focusing on solutions that improve patient outcomes. Contact us for more information.

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54 76 108

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ISO/TC 210/WG5, Connectors for reservoir delivery systems • Melbourne, Australia

ISO/TC 210-IEC/SC 62D/JWG4, Small-bore connectors • Melbourne, Australia

Sunday Monday

February 2015

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December 2014

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7 8 9 10 11 12 1314 15 16 17 18 19 2021 22 23 24 25 26 2728 29 30 31

Human Factors for Medical Devices • London, England

Application deadline for CQSM and CHTM Certification Exams

New Year’s Day

Martin Luther King Day

3D art illustration of an active brain

www.aami.org

Sunday Monday Tuesday Wednesday Thursday Friday Saturday

Fluke Biomedical Division of Fluke Electronics Corporation6920 Seaway Blvd, Everett, WA 98203(425) 347-6100(425) 446-5116www.flukebiomedical.com

Booth #511 at theAAMI 2015 Conference & Expo

Fluke Biomedical leads the world in the design and manufacture of biomedical test and diagnostic imaging solutions for quality assurance and compliance.

February 2015

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98 1110 1412

1615 1817 20 2119

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Quality System Requirements and Industry Practice • Orlando, FL

March 2015

S M T W T F S1 2 3 4 5 6 78 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30 31

January 2015

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4 5 6 7 8 9 1011 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 31

Groundhog Day

Valentine’s Day

Presidents’ Day

AAMI 2015 Conference & Expo early bird registration deadline

How do you compare? Benchmark your organization’s policies, processes, and procedures. Tools available for sterilization, QS/RA, and healthcare technology management. Visit www.aami.org/publications/benchmarking.

3D render of Staphylococcus microbeswww.aami.org


Toxikon [email protected]

Toxikon Corporation, headquartered in the Boston metro area, is a Contract Research Organization (CRO), with ISO/IEC 17025 accreditation & registration with the US FDA. Toxikon, a leader in biocompatibility, E&L, and Toxicology, provides non-clinical, in vivo, in vitro, & analytical testing services for the pharma, biotech, and med device sectors.

March 2015

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Train-the-Trainer • Arlington, VADesign Control Requirements and Industry Practice • Arlington, VA

Human Factors for Medical Devices • Alexandria, VA

Integrating Risk Management into the Quality System • Bethesda, MD

Quality System Requirements and Industry Practice • Boston, MA

Safety Assurance Cases for Medical Devices Arlington, VA

February 2015

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April 2015

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5 6 7 8 9 10 1112 13 14 15 16 17 1819 20 21 22 23 24 2526 27 28 29 30

Application deadline for CBET, CRES, & CLES Certification Exams

ISO/TC 210/JWG4, Small-bore connectors Arlington, VA ISO/TC 210/WG5,

Connectors for reservoir delivery systems Arlington, VA

Testing period begins for CQSM and CHTM Certification Exams

Testing period ends for CQSM and CHTM Certification Exams

Daylight Saving Time starts

St. Patrick’s Day

Artery shown with a cut out section and fat cells in the blood.www.aami.org


KARL STORZ Endoscopy-America, Inc.2151 E. Grand Ave. El Segundo, CA 90245

Phone: (800) 421-0837Fax: (800) 321-1304Email: [email protected] Website: www.karlstorz.com

KARL STORZ is the world leader in video and operating room integration solutions for minimally invasive surgery in virtually every specialty.

April 2015

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65 87 119

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2019 2221 24 2523

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AAMI Sterilization Standards Week • Annapolis, MD

Purchasing Controls & Supply Chain Management Arlington, VA

Process Validation Requirements and Industry Practice • Alexandria, VA

Quality System Requirements and Industry Practice • Sydney, Australia

Corrective and Preventive Action Requirements and Industry Practice • Arlington, VA

Regulatory Requirements for Software Validation In the Medical Device Industry Baltimore, MD

Design Control: The In-tersection of Human Fac-

tors, Industrial Design, and Risk Management

Baltimore, MD

Advanced Topics in Human Factors Baltimore, MD

March 2015

S M T W T F S1 2 3 4 5 6 78 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30 31

May 2015

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3 4 5 6 7 8 910 11 12 13 14 15 1617 18 19 20 21 22 2324 25 26 27 28 29 3031

AAMI/FDA S3 Challenge • Herndon, VA



Easter

Tax Day

Get involved in setting standards. For info on what is involved and how to join an AAMI committee, visit www.aami.org/standards.

Illustration of bacteria under a microscopewww.aami.org

Friday Saturday

Our purpose: To improve the lives of our employees, customers, business partners and communities one day at a time. Our Mission: To provide the medical community cost effective solutions for their clinical needs. How: Manufacture Replacement Parts for Medical Equipment and also offers Depot and On Site Repair Services across the US.

Elite Biomedical Solutions. www.elitebiomedicalsolutions.com (P) 855.291.6701 (F) [email protected]


May 2015

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1817 2019 22 2321

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Industrial Sterilization for Medical Devices • Alexandria, VA

Risk Management and Human FactorsArlington, VA

Sunday Monday Tuesday Wednesday Thursday

April 2015

S M T W T F S1 2 3 4

5 6 7 8 9 10 1112 13 14 15 16 17 1819 20 21 22 23 24 2526 27 28 29 30

June 2015

S M T W T F S1 2 3 4 5 6

7 8 9 10 11 12 1314 15 16 17 18 19 2021 22 23 24 25 26 2728 29 30

Testing period begins for CBET, CRES, & CLES Certification Exams

Testing period ends for CBET, CRES, & CLES Certification Exams

Mother’s Day

Memorial Day

HTM Week

Purchasing Controls & Supply Chain Management

Arlington, VA

A statue of a bronco outside Sports Authority Field.

Photo credit: Greg Throw and VISIT DENVER


Draeger Medical, Inc.1-800-437-2437www.draeger.com/draegerservice


At Dräger, our primary goal is to put your mind at ease when it comes to the maintenance of your medical equipment. As the original equipment manufacturer (OEM), we have a vested interest in the performance of your Dräger devices. DrägerService® has a number of flexible contract options from which to choose. Combinations with additional options will tailor the service solution to your specific needs.

June 2015

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87 109 1311

1514 1716 19 2018

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12

ISO/TC 121, Subcommittees and (Joint) Working Groups, DIN • Berlin, Germany

AAMI 2015 Annual Conference & Expo • Denver, CO

AAMI 2015 Annual Conference • Denver, CO

Quality System Requirements and Industry Practice • Bethesda, MD

Design Control Requirements and Industry Practice • New Orleans

May 2015

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July 2015

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CBET, CRES, & CLES Certification Exams (Denver, CO only)

AAMI Standards Week • Denver, CO



Posing for a picture in front of the big Blue Bear at the Colorado

Convention Center

Photo credit: Rich Grant and VISIT DENVER

Father’s Day

Free radicals and human cellswww.aami.org


July 2015

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65 87 119

1312 1514 17 1816

2019 2221 24 2523

2726 2928 3130

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ISO/TC 210-IEC/SC 62D/JWG4, Small-bore connectors • Morschen, GermanyISO/TC 210/WG5, Morschen, Germany

ISO/TC 210/WG5, Morschen, Germany

Toxikon [email protected]

Toxikon Corporation, headquartered in the Boston metro area, is a Contract Research Organization (CRO), with ISO/IEC 17025 accreditation & registration with the US FDA. Toxikon, a leader in biocompatibility, E&L, and Toxicology, provides non-clinical, in vivo, in vitro, & analytical testing services for the pharma, biotech, and med device sectors.

June 2015

S M T W T F S1 2 3 4 5 6

7 8 9 10 11 12 1314 15 16 17 18 19 2021 22 23 24 25 26 2728 29 30

August 2015

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2 3 4 5 6 7 89 10 11 12 13 14 1516 17 18 19 20 21 2223 24 25 26 27 28 2930 31


Independence DayShop the AAMI Store 24 hours a day

at my.aami.org. Preview the table of contents and introductory material before you buy.

Medical 3D illustration of Endothelium, human blood cellswww.aami.org

Tuesday Wednesday Thursday Friday Saturday

MediMizer, Inc. is home to industry standard biomedical compliance inspection software. Our staff has a collective 75 years’ biomedical industry experience. Offering Biomedical management software (CMMS), web requests, e-mail notification, mobile device software, dashboards, and scheduled reporting.

MediMizer, Inc.+1-888-838-4440+1-760-642-2002www.MediMizer.com


August 2015

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Human Factors for Medical Devices • Alexandria, VA

MondaySunday

July 2015

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September 2015

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Looking for more out of your AAMI membership? Join a committee, submit an article, participate in the AAMIBlog, or join a discussion group. Visit www.aami.org/membership/involved.html for more ideas on how to get involved.

Illustration of an active nerve cellwww.aami.org


Infusion Nurses Society (INS)315 Norwood Park SouthNorwood, MA [email protected]

The Infusion Nurses Society (INS), located in Norwood, MA, is the premier professional organization for infusion nursing. For more than 40 years, INS has been committed to bringing innovative new resources and opportunities to a wide range of healthcare professionals who are involved with the specialty practice of infusion therapy. We are dedicated to advancing the delivery of quality therapy to patients, enhancing the specialty through stringent standards of practice and professional ethics, and promoting research and education in the infusion nursing practice.

September 2015

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2827 3029

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ISO TC 150 meeting • Berlin, Germany

Quality System Requirements and Industry Practice • Munich, Germany

Ethylene Oxide Sterilization for Medical Devices • San Diego, CA

Integrating Risk Management into the Quality System • Alexandria, VA

Quality System Requirements and Industry Practice • Arlington, VA

Radiation Sterilization for Medical Devices • Arlington, VA

August 2015

S M T W T F S1

2 3 4 5 6 7 89 10 11 12 13 14 1516 17 18 19 20 21 2223 24 25 26 27 28 2930 31

October 2015

S M T W T F S1 2 3

4 5 6 7 8 9 1011 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 31




Labor Day

AAMI/FDA Summit • Washington, DC area

Film X-ray showing bones of human handswww.aami.org


Potomac [email protected]


Trust deconex® POWER ZYME enzymatic cleaner to lead the way. With a protease, alpha-amylase, lipase, and cellulase enzyme deconex® POWER ZYME has the power to remove even the toughest surgical debris. The neutral pH of deconex® POWER ZYME relieves your worries of handling caustic chemistry.

October 2015

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AAMI Sterilization Standards Week • Silver Spring, MD

Radiation Sterilization for Medical Devices

Arlington, VA

Effective Application of Agile Practices in the Development of Medical Device Software

Arlington, VA

Process Validation Requirements and Industry Practice • Orlando, FL

Developing and Validating Software for the Medical Device Industry Las Vegas, NV

Design Control Requirements and Industry Practice • Alexandria, VA


September 2015

S M T W T F S1 2 3 4 5

6 7 8 9 10 11 1213 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30

November 2015

S M T W T F S1 2 3 4 5 6 78 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

Human Factors for Medical Devices • London, England


Columbus Day

Halloween

Resolutions aren’t just for January. Become certified. Learn how at www.aami.org/certification. New: AAMI members receive a 20% discount on the exam.

Bipolar neuronswww.aami.org


November 2015

21 43 6 75

98 1110 1412

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Human Factors for Medical Devices • Arlington, VA

KARL STORZ Endoscopy-America, Inc.2151 E. Grand Ave. El Segundo, CA 90245

Phone: (800) 421-0837Fax: (800) 321-1304Email: [email protected] Website: www.karlstorz.com

KARL STORZ is the leader in Rigid and Flexible endoscopes for minimally invasive surgery. Call us to safeguard your investment against faulty repairs.

October 2015

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4 5 6 7 8 9 1011 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30 31

December 2015

S M T W T F S1 2 3 4 5

6 7 8 9 10 11 1213 14 15 16 17 18 1920 21 22 23 24 25 2627 28 29 30 31

Testing period begins for CBET, CRES, & CLES Certification Exams

Testing period ends for CBET, CRES, & CLES Certification Exams

Daylight Saving Time ends

Election Day

Veteran’s Day

Thanksgiving

Get a jump on 2016! Do you need any AAMI resources? Have you made plans for the AAMI 2016 Annual Conference & Expo?

Zygotewww.aami.org


MediMizer, Inc. is home to industry standard biomedical compliance inspection software. Our staff has a collective 75 years biomedical industry experience. Offering Biomedical management software (CMMS), web requests, e-mail notification, mobile device software, dashboards, and scheduled reporting.

MediMizer, Inc.+1-888-838-4440+1-760-642-2002www.MediMizer.com


January 2016

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December 2015

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Design Control Requirements and Industry Practice • San Francisco, CA


November 2015

S M T W T F S1 2 3 4 5 6 78 9 10 11 12 13 1415 16 17 18 19 20 2122 23 24 25 26 27 2829 30

AAMI Standards Week • TBD



Chanukah

Christmas Eve Christmas Day Kwanzaa

New Year’s Eve

EDUCATION

AAMI Annual Conference & Expo—This premier industry event will bring 1,700+ healthcare technology management professionals from across the nation and around the world to Denver, June 5-8, 2015, for four days full of learning opportunities, networking, and to see the latest innovations, upgrades, and advances in healthcare technology. For details, visit www.aami.org/ac.

The AAMI/FDA S3 Challenge—an interactive forum on the use of standards from AAMI and the FDA—April 1-2, 2015 in Herndon, VA. Leaders from industry and government to collaborate on finding solutions to the challenges facing the healthcare technology industry—including the need for greater synthesis in the development, application, and interactions of medical device standards—to improve the safety of medical technology and reduce the time it takes to bring new devices to market. For details, visit www.aami.org/S3.

Industry Training Programs—AAMI is offering 29 training sessions in 2015 on topics such as quality systems, human factors, purchasing controls, design control, process validation, risk management, software validation, corrective and preventive action (CAPA) requirements, safety assurance cases, Agile practices, industrial sterilization, radiation sterilization, and ethylene oxide sterilization. For detailed training program descriptions, dates, and locations, visit university.aami.org. To bring the programs in-house to your organization, contact Jeanine Beisel at [email protected].

CERTIFICATION

Enhance your knowledge, advance your career, and contribute to improving patient safety by earning one or more of the following healthcare technology-focused certifications:

CQSM: Certified Quality System Manager NEW! CHTM: Certified Healthcare Technology Manager NEW! CBET: Certified Biomedical Equipment Technician CRES: Certified Radiology Equipment Specialist CLES: Certified Laboratory Equipment Specialist

For exam dates and deadlines, visit www.aami.org/certification. AAMI members receive a 20% discount on the exam fee.

MEMBERSHIP

Benefits—AAMI members enjoy numerous benefits including a weekly digital newsletter; a monthly newsletter; a bimonthly journal; deep discounts on standards, publications, and educational events; career guidance; networking opportunities; awards recognition; and much more. To learn more about AAMI or renew your membership, visit www.aami.org/membership or call 800-332-2264, ext. 1214.

PUBLICATIONS/WEBSITE

Submitting articles—AAMI welcomes submissions about healthcare technology. To learn more about submitting articles, visit www.aami.org/publications/BIT.

Advertising—AAMI offers several avenues to reach the decision makers in healthcare technology: through AAMI publications, the website, podcasts, electronic newsletters, and the Annual Conference & Expo. For more information on marketing opportunities, visit www.aami.org/advertising.

Career Services—AAMI members can post resumes for free at AAMI’s online Career Center. AAMI members also receive a 50% discount when posting job openings. Visit www.aami.org/career.

STANDARDS

Buying Standards—To browse AAMI products or to purchase products and services, visit http://my.aami.org/store. You can also call AAMI’s Customer Service Department at 877-249-8226.

Developing Standards—The AAMI standards program consists of more than 100 technical committees and working groups that produce standards, recommended practices, and technical information reports for medical devices. To get involved, visit www.aami.org/standards. For an up-to-date list of technical committee meetings, visit www.aami.org/meetings.html.

AAMI Resources

www.aami.org

Visitors gaze up inside the Colorado Capitol.

Photo credit: Stan Obert and VISIT DENVER

Denver City and County Building with special lighting in Denver Broncos colors for the 2013 NFL Playoffs

2016 At a Glance

Calendar Sponsors

January 2016

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February 2016

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March 2016

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April 2016

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3 4 5 6 7 8 910 11 12 13 14 15 1617 18 19 20 21 22 2324 25 26 27 28 29 30

May 2016

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June 2016

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5 6 7 8 9 10 1112 13 14 15 16 17 1819 20 21 22 23 24 2526 27 28 29 30

July 2016

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3 4 5 6 7 8 910 11 12 13 14 15 1617 18 19 20 21 22 2324 25 26 27 28 29 3031

August 2016

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7 8 9 10 11 12 1314 15 16 17 18 19 2021 22 23 24 25 26 2728 29 30 31

September 2016

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4 5 6 7 8 9 1011 12 13 14 15 16 1718 19 20 21 22 23 2425 26 27 28 29 30

October 2016

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November 2016

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December 2016

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AAMI 2016 Conference & Expo June 3 – 6, Tampa, FL

4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633

Phone: +1-703-525-4890E-mail: [email protected]

Web: www.aami.org

To order AAMI products, please contact the Customer Service Department at +877-249-8226.