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AAMI ST/WG 84 Interim Meeting, July 2018

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Description: AAMI ST/WG 84, Endoscope Reprocessing, will be meeting at AAMI's office in Arlington, VA on July 19 & 20, 2018.

Please register below. Registration is necessary to ensure proper accommodations.
You must log in or create a profile in order to register.

Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

Due to space limitations, in-person attendance will be limited to Primary or Alternate members of the working group. A web/teleconference participation option will be available.
ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. Web/teleconference details will be provided to registrants after registration closes.

Start Date:
Thursday, July 19, 2018
End Date:
Friday, July 20, 2018
Address:
AAMI Headquarters
4301 North Fairfax Drive, Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


Design Control Requirements & Industry Practice Course

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Description:

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products.

An optional exam is available online for 2 weeks following the end of the program.

Start Date:
Wednesday, August 29, 2018
End Date:
Friday, August 31, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Design Control Requirements and Industry Practice

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Description:

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products.

An optional exam is available online for 2 weeks following the end of the program.

Start Date:
Wednesday, September 05, 2018
End Date:
Friday, September 07, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Munich Airport Marriott Hotel
Alois Steinecker Strasse 20
85354 Freising, Germany
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Design Control Requirements and Industry Practice

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Description: Please note Start time of 12:00 Noon.

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products.

An optional exam is available online for 2 weeks following the end of the program.

Start Date:
Wednesday, September 12, 2018
End Date:
Friday, September 14, 2018
Time:
12:00 PM - 5:00 PM Eastern Daylight Time
Address:
Level 8 Meeting Rooms, Building 1
ITRI, 321 Sec 2, Kuang Fu Rd.
Hsinchu 30011
TAIWAN
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


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

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Description:

Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software.

Hotel Reservation Link



Start Date:
Monday, October 15, 2018
End Date:
Tuesday, October 16, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Bally's Las Vegas
3645 S Las Vegas Blvd
Las Vegas, NV 89109
UNITED STATES
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


Ethylene Oxide Sterilization for Medical Devices Course

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Description:

This highly interactive 3.5-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.

Hotel Reservation Link



Start Date:
Tuesday, August 28, 2018
End Date:
Friday, August 31, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Rado
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Human Factors for Medical Devices

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Description:

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Hotel Reservation Link



Start Date:
Monday, October 15, 2018
End Date:
Wednesday, October 17, 2018
Address:
Royal Marine Hotel Dublin
Marine Rd
DUN LAOGHAIRE, DUBLIN
IRELAND
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,235.00


Human Factors for Medical Devices Course

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Description:

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Hotel Reservation Link



Start Date:
Monday, September 17, 2018
End Date:
Wednesday, September 19, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Westin Arlington Gateway
801 North Glebe Rado
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Human Factors for Medical Devices Course

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Description:

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Hotel Reservation Link



Start Date:
Tuesday, June 26, 2018
End Date:
Thursday, June 28, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester England UK
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Industrial Sterilization for Medical Devices

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Description:

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Hotel Reservation Link



Start Date:
Monday, December 03, 2018
End Date:
Thursday, December 06, 2018
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester England
UNITED KINGDOM
AAMI Member
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00


Integrating Risk Management Into the Quality System

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Description: This comprehensive 2.5 day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the lifecycle of the product, from design…to manufacturing…through post-production.
Start Date:
Monday, September 10, 2018
End Date:
Wednesday, September 12, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Level 8 Meeting Rooms, Building 1
ITRI, 321 Sec 2, Kuang Fu Rd.
Hsinchu 30011
TAIWAN
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


Process Validation Requirements and Industry Practice

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Description:

This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA's Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post-test which is available online for 2 weeks following the end of the program, will be available to all participants.

Hotel Reservation Link

Start Date:
Wednesday, October 24, 2018
End Date:
Friday, October 26, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$2,135.00
List Price
$2,435.00


Radiation Sterilization for Medical Devices

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Description:

This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Hotel Reservation Link

Start Date:
Tuesday, October 16, 2018
End Date:
Friday, October 19, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Software Validation Workshop: Practical Tools & Techniques

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Description:

This 3 day course supplies attendees with practical tools and techniques for software validation for embedded device software, Off-The-Shelf software, and Quality System (Non-Device) software. It includes real life software validation examples utilizing Engineering & Software Quality "best practices." The workshop includes practical information on a variety of topics such as writing useful & testable requirements, techniques for testing, and streamlining quality processes for development and validation efforts.

Hotel Reservation Link



Start Date:
Wednesday, October 17, 2018
End Date:
Friday, October 19, 2018
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Bally's Las Vegas
3645 S Las Vegas Blvd
Las Vegas, NV 89109
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


The Application of Agile to the Development of Medical Device Systems

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Description:

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile's Lean Product Development principles also apply to the development of hardware-based products and systems. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

Hotel Reservation Link

Start Date:
Wednesday, September 19, 2018
End Date:
Friday, September 21, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
AAMI Headquarters
4301 North Fairfax Drive Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,135.00
List Price
$950.00 - $2,435.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

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Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, December 03, 2018
End Date:
Friday, December 07, 2018
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester England
UNITED KINGDOM
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

/aamiresources/images/events/WestinArlingtonGateway.jpg
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, September 24, 2018
End Date:
Friday, September 28, 2018
Address:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,150.00 - $2,985.00
List Price
$1,150.00 - $3,285.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

/aamiresources/images/events/itri.jpg
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, July 23, 2018
End Date:
Friday, July 27, 2018
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Address:
Level 8 Meeting Rooms, Building 1
ITRI, 321 Sec 2, Kuang Fu Rd.
Hsinchu 30011
TAIWAN
AAMI Member
$1,150.00 - $2,935.00
List Price
$1,150.00 - $3,285.00


The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

/aamiresources/images/events/royalmarine_dublin.jpg
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
Start Date:
Monday, October 01, 2018
End Date:
Friday, October 05, 2018
Address:
Royal Marine Hotel Dublin
Marine Rd
DUN LAOGHAIRE, DUBLIN
IRELAND
AAMI Member
$1,150.00 - $2,935.00
List Price
$1,150.00 - $3,285.00