NAMSA eLearning tools provide a convenient way to access industry training on globally relevant topics from anywhere there is internet access. These modules are available in an entire course series or as a single training session. Training modules each include an evaluation tool upon completion, and provide a certificate upon satisfactory score. Our eLearning tools bring NAMSA experts and their industry insight directly to your personal computer.


E-Learning Courses

Course Dates: September 9, 2016 - No End Date
Price: 
$1,625.00 (tax incl.)

The ISO 10993 series of standards are used by medical device manufacturers for the evaluation of biological safety, more commonly referred to as biocompatibility.

E-Learning Webinars

Course Dates: April 14, 2017 - No End Date
Price: FREE

On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff." Learn about the updates since the 2013 Draft Guidance, what the changes mean, how you should prepare and more.

Course Dates: April 14, 2017 - No End Date
Price: FREE

Human factors research provides validity and value to the dynamic medical device design, manufacturing and approval processes. Proper implementation improves safety outcomes by assessing how users interact with a medical device and interface design of the device. 

Course Dates: April 14, 2017 - No End Date
Price: FREE

During this webinar, attendees will learn about the tests involved in the new USP 661.1 for each polymer group, as well as options and views for addressing other polymers, copolymers, and packaging systems.

Course Dates: April 7, 2017 - No End Date
Price: FREE

SAE reporting is always a very critical part of a Clinical Trial, and within the EU, differences between requirements by national Law between the EU Member States also appear.

Course Dates: April 7, 2017 - No End Date
Price: FREE

Throughout the device development process, preclinical testing plays an important role in developing, evaluating, and even marketing a particular product.  From feasibility through Good Laboratory Practice (GLP), different types of studies serve to investigate different aspects of development. 

Course Dates: April 14, 2017 - No End Date
Price: FREE

Obtaining full FDA approval of an Investigational Device Exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device

Course Dates: April 14, 2017 - No End Date
Price: FREE

Risk-based monitoring (RBM) extends beyond the idea of simply reducing onsite monitoring by performing less than 100% source document verification. Rather, a comprehensive implementation of RBM can provide an adaptable, integrated approach to monitoring that focuses on identifying and addressing risks to patient safety and data quality.

Course Dates: April 17, 2017 - No End Date
Price: FREE

On June 16, 2016 the FDA officially released the much-anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff. You can read the update here.

Course Dates: April 17, 2017 - No End Date
Price: FREE

On May 25th 2016 the European Commission released the long awaited draft for the proposed European Medical Device Regulation (MDR). Though not in its final implementation format, the consolidated text is expected to be translated into the 24 official European working languages prior ratification by the European Parliament in late 2016/early 2017. The transition period is 3 (three) years ending in late 2019/early 2020. By the end of the transition period, all medical devices have to comply with these new regulatory requirements in Europe.

Course Dates: March 29, 2017 - March 29, 2018
Price: FREE

Bioskills is an essential part of any medical device development program for the testing and verification of the intended use and performance of a medical device, IVD or regenerative medicine product. It also serves as a critical step for medical device manufacturers and health care professionals to facilitate cross-functional interaction and learning that leads to the efficient development of new and innovative medical technologies.

E-Learning Courses

Course Dates: September 9, 2016 - No End Date
Price: 
$1,625.00 (tax incl.)

The ISO 10993 series of standards are used by medical device manufacturers for the evaluation of biological safety, more commonly referred to as biocompatibility.

E-Learning Webinars

Course Dates: April 14, 2017 - No End Date
Price: FREE

On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff." Learn about the updates since the 2013 Draft Guidance, what the changes mean, how you should prepare and more.

Course Dates: April 14, 2017 - No End Date
Price: FREE

Human factors research provides validity and value to the dynamic medical device design, manufacturing and approval processes. Proper implementation improves safety outcomes by assessing how users interact with a medical device and interface design of the device. 

Course Dates: April 14, 2017 - No End Date
Price: FREE

During this webinar, attendees will learn about the tests involved in the new USP 661.1 for each polymer group, as well as options and views for addressing other polymers, copolymers, and packaging systems.

Course Dates: April 7, 2017 - No End Date
Price: FREE

SAE reporting is always a very critical part of a Clinical Trial, and within the EU, differences between requirements by national Law between the EU Member States also appear.

Course Dates: April 7, 2017 - No End Date
Price: FREE

Throughout the device development process, preclinical testing plays an important role in developing, evaluating, and even marketing a particular product.  From feasibility through Good Laboratory Practice (GLP), different types of studies serve to investigate different aspects of development. 

Course Dates: April 14, 2017 - No End Date
Price: FREE

Obtaining full FDA approval of an Investigational Device Exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device

Course Dates: April 14, 2017 - No End Date
Price: FREE

Risk-based monitoring (RBM) extends beyond the idea of simply reducing onsite monitoring by performing less than 100% source document verification. Rather, a comprehensive implementation of RBM can provide an adaptable, integrated approach to monitoring that focuses on identifying and addressing risks to patient safety and data quality.

Course Dates: April 17, 2017 - No End Date
Price: FREE

On June 16, 2016 the FDA officially released the much-anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff. You can read the update here.

Course Dates: April 17, 2017 - No End Date
Price: FREE

On May 25th 2016 the European Commission released the long awaited draft for the proposed European Medical Device Regulation (MDR). Though not in its final implementation format, the consolidated text is expected to be translated into the 24 official European working languages prior ratification by the European Parliament in late 2016/early 2017. The transition period is 3 (three) years ending in late 2019/early 2020. By the end of the transition period, all medical devices have to comply with these new regulatory requirements in Europe.

Course Dates: March 29, 2017 - March 29, 2018
Price: FREE

Bioskills is an essential part of any medical device development program for the testing and verification of the intended use and performance of a medical device, IVD or regenerative medicine product. It also serves as a critical step for medical device manufacturers and health care professionals to facilitate cross-functional interaction and learning that leads to the efficient development of new and innovative medical technologies.