The document is a calendar for 2015 that provides information about various events related to medical devices and healthcare technology management. It lists the dates of each month in 2015 along with relevant events, locations, registration deadlines, and advertisements from companies in the medical device industry.
There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales'both in the U.S. and worldwide'and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales'both in the U.S. and worldwide'and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.
What You Need to Know About Medical Electrical Standards Updates (and how the...Greenlight Guru
Medical Electrical Standards are constantly being updating.
So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?
This presentation will cover:
-What medical electrical and related standards are being updated now and how they interact with each other.
-What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
-Overview of the recently released Wireless Coexistence Standards for US.
-Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
-How does testing under the CB Scheme impact your testing and regulatory strategies?
-Resources to keep track of standards from both a regulatory and standards development perspective.
Watch the presentation here: https://www.greenlight.guru/webinar/medical-electrical-standards-updates
What data can you use to drive your business and improve product design? CPSC has databases you can use to look for product problems by searching through consumer product-related incidents, injuries and deaths to take proactive action and minimize risk. CPSC experts will discuss how these databases are used by CPSC internally to examine potential actions; how to search and use CPSC’s national injury database (NEISS) and SaferProducts.gov to identify problems; and how these databases may benefit business and industry in promoting safer products.
IEC 60601-1-11 is a mandatory standard provision geared toward determining and documenting failure and hazard potential of medical electrical equipment intended for home use. By addressing the challenges associated with regulating the use of medical devices in the home, we've identified key performance requirements that must be considered when designing a medical device for use outside of the traditional clinical environment.
Environmental Compliance - Today And TomorrowSebastian Nowak
A look at today\'s environmental compliance challenges, what the future holds in store, and how the TUV Rheinland Compliance Platform can help you to avoid potential risks.
SIETAR Europe: Effective Use of Technology for a Coherent Third Culture Creat...Ralf Wolter
Session abstract:
The availability of affordable and reliable technology, coupled with market demands, allows trainers and coaches to reach clients around the globe. This global reach via virtual communication technology requires trainers and coaches to increase their comfort and understanding of technology and cultural implications on the learning experience.
One of the key questions to be addressed is how cultural differences impact the conversation via communication technology?Beyond respecting other cultures success involves adapting to other cultures where all parties contribute to the creation of a third culture. In that there is not a one size fits all solution. The culture-general frameworks shared during this workshop can be adapted to help give virtual training and coaching sessions a local touch making them more effective.This dynamic workshop provides participants with a structured approach and culture general frameworks as well as practical tips that enable them to prepare and deliver their virtual workshops and coaching sessions tailoring their content or process to their audience.
Objective: This workshop is designed to address the influence of culture on the use of communication technologies in intercultural training and how to create coherent virtual third cultures to communicate most effectively.
Evaluation des iSIPS IP Stack für drahtlose SensornetzePeter Rothenpieler
Vortrag auf dem IPv6-Kongress 2013 in Frankfurt/Main (6./7.06.2013, Cinestar Metropolis) zum Thema "Evaluation des iSIPS IP Stack für Drahtlose Sensornetze"
What data can you use to drive your business and improve product design? CPSC has databases you can use to look for product problems by searching through consumer product-related incidents, injuries and deaths to take proactive action and minimize risk. CPSC experts will discuss how these databases are used by CPSC internally to examine potential actions; how to search and use CPSC’s national injury database (NEISS) and SaferProducts.gov to identify problems; and how these databases may benefit business and industry in promoting safer products.
IEC 60601-1-11 is a mandatory standard provision geared toward determining and documenting failure and hazard potential of medical electrical equipment intended for home use. By addressing the challenges associated with regulating the use of medical devices in the home, we've identified key performance requirements that must be considered when designing a medical device for use outside of the traditional clinical environment.
Environmental Compliance - Today And TomorrowSebastian Nowak
A look at today\'s environmental compliance challenges, what the future holds in store, and how the TUV Rheinland Compliance Platform can help you to avoid potential risks.
SIETAR Europe: Effective Use of Technology for a Coherent Third Culture Creat...Ralf Wolter
Session abstract:
The availability of affordable and reliable technology, coupled with market demands, allows trainers and coaches to reach clients around the globe. This global reach via virtual communication technology requires trainers and coaches to increase their comfort and understanding of technology and cultural implications on the learning experience.
One of the key questions to be addressed is how cultural differences impact the conversation via communication technology?Beyond respecting other cultures success involves adapting to other cultures where all parties contribute to the creation of a third culture. In that there is not a one size fits all solution. The culture-general frameworks shared during this workshop can be adapted to help give virtual training and coaching sessions a local touch making them more effective.This dynamic workshop provides participants with a structured approach and culture general frameworks as well as practical tips that enable them to prepare and deliver their virtual workshops and coaching sessions tailoring their content or process to their audience.
Objective: This workshop is designed to address the influence of culture on the use of communication technologies in intercultural training and how to create coherent virtual third cultures to communicate most effectively.
Evaluation des iSIPS IP Stack für drahtlose SensornetzePeter Rothenpieler
Vortrag auf dem IPv6-Kongress 2013 in Frankfurt/Main (6./7.06.2013, Cinestar Metropolis) zum Thema "Evaluation des iSIPS IP Stack für Drahtlose Sensornetze"
Quality and HR Manager in IT sector (Looking For New Challenges) Bilbao y alrededores / Servicios y Tecnologías de la Información Interés en crecer y evolucion...
Program - American Chemical Manufacturing Summit 2013, PittsburghMark Blendheim
The American Chemical Manufacturing Summit brings together industry leaders to discuss the current state of the industry and the impact of new regulations. The summit provides chemical manufacturing, quality and supply chain executives valuable insight into new manufacturing strategies, technology and Operational Excellence.
Read the newest edition of Innovations™ Magazine today!
Welcome to the summer issue of Innovations™ Magazine,
where industry experts from across the globe explore many of the pressing challenges — and successes — of pressurized piping operators.
Corrosion: The Pervasive Menace
Helping the public be – and feel – safe, the pipeline industry develops, employs, and shares best practice corrosion detection and control methods.
Turning Impossible into Piggable
Changing how we think about the integrity of low flow, low pressure lines with new low drag inspection tools.
More Stringent Safety Regulations
Preparing for NTSB compliance, U.S. transmission operators proactively seek safe and cost-effective options.
Local Sourcing in the Eagle Ford
Supporting shale play profitability in a low price environment through localized pipeline services model.
Moving Forward: Setting The Direction - A Findings Review of CTEK’s 2020 Annu...SophiaPalmira
In this session, we will do a deep-dive into the NIST Cybersecurity Framework assessment results for our healthcare clients. We will look at process maturity for each of the functional areas of the NIST CSF: Identity, Protect, Detect, Respond, and Recover. In addition, we will look at the main driver of risk in 2019, and what trends we are seeing from the first half of 2020.
2012 to 2013 Australian Hospital Digital Scanning Surveysquareearth
Results undertaken from the Australian hospital digital scanning survey undertaken in 2014, for 2012-13 data. Report undertaken by SquareEarth, a healthcare consultancy firm.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
We are happy to share with you, our monthly News letter “Tech-Talk” which is designed tobe an emental source for leading information related to developing technologies, ingenious techniques and innovative approaches.
Webinar slides on Data Integrity 101
Organized by: One Quality Solutions Ltd.
Date: 19 May 2023
Time: 09:00-10:00 pm (BST)
Data Integrity in Pharmaceutical Industry is a hot topic now. Due to emerging technology, maintaining integrity of data is a very big challenge. If the challenges are not managed appropriately, there is high potential to receive regulatory enforcement actions including FDA 483s, warning letter or shut down of the pharmaceutical plant. So, it is very important to understand the basic requirements of Data Integrity.
Topics:
1. Introduction to Data Integrity
What is Data Integrity?
Why it is important?
Key Definitions
2. ALCOA+ Principles
History of ALCOA+
ALCOA+ and ALCOA++
3. Document Control
Example observation from Warning Letter
How to implement document control?
4. User Access Management
Example observation from Warning Letter
How to implement user access management?
5. Audit Trail Review
Example observation from Warning Letter
How to implement audit trail review?
Speakers:
Mohammed Raihan Chowdhury
Head of Quality Systems and Services
One Quality Solutions Ltd.
Ex-Data Integrity Lead of Novartis Bangladesh
and
Sharmin Afroz
Sr. Asst. Manager, Product Development-ARD
Data Integrity Expert of Laboratory Instrument
Radiant Pharmaceuticals Ltd.
Bangladesh
Host:
Najmun Nahar
Marketing Executive
One Quality Solutions Ltd.
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
3. Tuesday Wednesday Thursday Friday Saturday
January 2015
Nelson Laboratories, Inc.
www.nelsonlabs.com
801-290-7500
sales@nelsonlabs.com
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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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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Human Factors for Medical Devices • London, England
Application deadline
for CQSM and CHTM
Certification Exams
New Year’s Day
Martin Luther
King Day
5. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Fluke Biomedical Division of Fluke
Electronics Corporation
6920 Seaway Blvd, Everett, WA 98203
(425) 347-6100
(425) 446-5116
www.flukebiomedical.com
Booth #511 at the
AAMI 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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Quality System Requirements and Industry Practice • Orlando, FL
March 2015
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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.
7. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Toxikon Corporation
www.toxikon.com
800.458.4141
info@toxikon.com
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
21 43 6 75
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Train-the-Trainer • Arlington, VA
Design 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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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
8. Artery shown with a cut out
section and fat cells in the blood.www.aami.org
9. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo, CA 90245
Phone: (800) 421-0837
Fax: (800) 321-1304
Email: communications@karlstorz.com
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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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
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AAMI/FDA S3
Challenge • Herndon, VA
Application deadline
for CBET, CRES, &
CLES Certification
Exams
Application deadline
for CQSM and CHTM
Certification Exams
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.
11. 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) 866.941.4887
customerservice@
elitebiomedicalsolutions.com
Booth #719 at the
AAMI 2015 Conference & Expo
May 2015
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Industrial Sterilization for Medical Devices • Alexandria, VA
Risk Management and Human Factors
Arlington, VA
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April 2015
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28 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
12. A statue of a bronco outside Sports Authority Field.
Photo credit: Greg Throw and VISIT DENVER
13. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Draeger Medical, Inc.
1-800-437-2437
www.draeger.com/
draegerservice
Booth #419 at the
AAMI 2015 Conference & Expo
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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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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CBET, CRES, & CLES
Certification Exams
(Denver, CO only)
AAMI Standards Week • Denver, CO
Testing period begins
for CQSM and CHTM
Certification Exams
Testing period ends
for CQSM and CHTM
Certification Exams
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
15. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
July 2015
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ISO/TC 210-IEC/SC 62D/JWG4, Small-bore connectors • Morschen, Germany
ISO/TC 210/WG5,
Morschen, Germany
ISO/TC 210/WG5,
Morschen, Germany
Toxikon Corporation
www.toxikon.com
800.458.4141
info@toxikon.com
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
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August 2015
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30 31
Application deadline
for CQSM and CHTM
Certification Exams
Independence
DayShop the AAMI Store 24 hours a day
at my.aami.org. Preview the table
of contents and introductory material
before you buy.
17. 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
+1-760-642-2002
www.MediMizer.com
Booth #119 at the
AAMI 2015 Conference & Expo
August 2015
1
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30 31
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.
19. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Infusion Nurses Society (INS)
315 Norwood Park South
Norwood, MA 02062
www.ins1.org
781-440-9408
ins@ins1.org
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
21 4 53
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11
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
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October 2015
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25 26 27 28 29 30 31
Application deadline
for CBET, CRES, &
CLES Certification
Exams
Testing period begins
for CQSM and CHTM
Certification Exams
Testing period ends
for CQSM and CHTM
Certification Exams
Labor Day
AAMI/FDA Summit • Washington, DC area
21. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Potomac Labs
www.potomaclabs.com
301-825-2831
info@potomaclabs.com
Booth #604 at the
AAMI 2015 Conference & Expo
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
2 31
54 76 108
1211 1413 16 1715
1918 2120 23 2422
2625 2827 30 3129
9
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
Quality System Requirements and Industry Practice • Arlington, VA
September 2015
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November 2015
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Human Factors for Medical Devices • London, England
Application deadline
for CQSM and CHTM
Certification Exams
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.
23. Sunday Monday Tuesday Wednesday Thursday Friday Saturday
November 2015
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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) 421-0837
Fax: (800) 321-1304
Email: communications@karlstorz.com
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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December 2015
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27 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?
25. Sunday Monday 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
+1-760-642-2002
www.MediMizer.com
Booth #119 at the
AAMI 2015 Conference & Expo
January 2016
S M T W T F S
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21 4 53
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Design Control Requirements and Industry Practice • San Francisco, CA
Quality System Requirements and Industry Practice • Arlington, VA
November 2015
S M T W T F S
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8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30
AAMI Standards Week • TBD
Testing period begins
for CQSM and CHTM
Certification Exams
Testing period ends
for CQSM and CHTM
Certification Exams
Chanukah
Christmas Eve Christmas Day Kwanzaa
New Year’s Eve
26. 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 jbeisel@aami.org.
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
27. 2016 At a Glance
Calendar Sponsors
January 2016
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September 2016
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December 2016
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AAMI 2016 Conference & Expo
June 3 – 6, Tampa, FL