NAMSA is committed to not only offering the most in-depth consulting, the best and most cutting edge laboratory testing as well the most efficient and productive clinical trial services but we are also committed to providing the latest information and thought leadership across the industry and across the globe. NAMSA webinars provide insights and understanding regarding today’s testing standards and tomorrow’s regulatory changes.

Upcoming Webinars


Previous Webinars

FDA Biological Evaluation Guidance

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 Learn about the updates since the 2013 Draft Guidance, what the changes mean, how you should prepare and more.

Applying Human Factors and Usability Engineering to Medical Devices

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. 

Updates to USP 661: USP 661.1 Plastic Materials of Construction

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.

SAE Reporting Requirements in Germany and Austria

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.

Preclinical Work Throughout the Medical Device Process

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. 

IDE Submission-Navigating an Efficient Path to Full Approval

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

Risk-Based Monitoring in Clinical Trial: A Cross-Functional Approach

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.

Panel Discussion on FDA Guidance: Use of ISO 10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process

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.

The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices

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.

Bioskills and it’s Role in Product Development

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.