9/14/2010 - 9/17/2010
***FULL: COURSE A
Biocompatibility of Medical Devices: Two Day Certification Course
Prerequisite: none
This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants must attend and complete all exercises to be certified as a biological safety specialist.
COURSE B
Regulatory Toxicology of Medical Devices: An Advanced Course
Prerequisite: Biocompatibility of Medical Devices: Two Day Certification Course
This 2-day training course is designed for those who have received certification in the NAMSA Advisory Services Biocompatibility of Medical Devices Two Day Certification Course. The objective of this course is to teach beyond the basics of Tables A and B in ISO 10993. In addition to traditional medical devices, we will address combination products and biologics. Participants will not only learn how to assess their device for biological risks but also understand when testing is necessary. They will discover where to find information and how to incorporate it into their assessments. Calculating safe limits will also be discussed. Hands-on workshops will provide an opportunity to work with case studies on real medical devices which will provide an understanding of how to present data in a submission. Participants will walk away with the knowledge of how to plan and a strategy to endure potential obstacles.
COURSE CTraditional and Novel Sterilization Methods of Medical Devices
Prerequisite: none
This training course discusses regulatory expectations for a sterile single use device (SUD), reusable devices, non-sterile SUDs, reprocessed SUDs and devices processed aseptically. By discussing ways of meeting regulatory expectations, and the key issues reviewers are looking for, this course will help you accelerate your product to market. We will examine the use of a validation master plan as well as preparing for various studies that are required to fulfill the plan. Radiation, moist heat and ethylene oxide sterilization methods will be discussed as well as packaging.
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10/18/2010 - 10/22/2010
COURSE A
Biocompatibility of Medical Devices: Two Day Certification Course
Prerequisite: none
This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants must attend and complete all exercises to be certified as a biological safety specialist.
COURSE C
Traditional and Novel Sterilization Methods of Medical Devices
Prerequisite: none
This training course discusses regulatory expectations for a sterile single use device (SUD), reusable devices, non-sterile SUDs, reprocessed SUDs and devices processed aseptically. By discussing ways of meeting regulatory expectations, and the key issues reviewers are looking for, this course will help you accelerate your product to market. We will examine the use of a validation master plan as well as preparing for various studies that are required to fulfill the plan. Radiation, moist heat and ethylene oxide sterilization methods will be discussed as well as packaging.
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MEDTEC - Galway
9/22/2010 - 9/23/2010
Galway, Ireland
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Hulst Expo
2/8/2011 - 2/10/2011
Koelnmesse, Cologne, Germany
NAMSA will also lead a work shop session on the new MDD 2007/47. View more information
6/28/2010
Alquest CEO Linda Alexander speaks on increasing FDA requirements
in BusinessWeek article.
http://www.businessweek.com/news/2010-06-23/cytori-breast-repair-device-gets-higher-hurdle-at-fda.html
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5/24/2010
NAMSA Adds to Sterilization Validation Offering - STERRAD STerilization Services Now Available
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5/19/2010
CeeTox acquires assets formerly owned by ADMETRx, Inc.
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5/13/2010
Kinetic-Turbidimetric Method Added to In Vitro Offering
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3/29/2010
Contract test laboratories adjust to requests for more device testing, details from the FDA.
http://www.mpo-mag.com/articles/2010/03/put-to-the-test
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12/17/2009
NAMSA announced that it completed its acquisition of Alquest, Inc. based in Minneapolis. Alquest is a leading contract research organization (CRO) specializing in regulatory strategy, compliance and clinical trials management for the medical device industry.
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12/9/2009
NAMSA's Sterilization Monitoring Products department discontinues stocking code STNS-65.
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10/14/2009
NAMSA's Sterilization Monitoring Products department joins forces with Package Care in Sri Lanka and RS Micromedia International in Bangladesh.
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9/1/2009
NAMSA's Analytical Chemistry and Materials Characterization department doubles its capacity for medical device testing.
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7/15/2009
NAMSA’s Microbiology lab confirms that new athletic Crocs™ are sterile and safe.
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