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.
04/17/2017 - 04/17/2018
|Reusable Medical Devices – Getting Market Clearance in the United States|
11:00 am EDT - 12:00 pm EDT
|The Purpose and Value of Chemical Characterization and Biological Risk Assessment in Medical Device Development|
10:00 am EDT - 11:00 am EDT
|EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider|
10:00 am EDT - 11:00 am EDT
|Clinical Trials in China- A Regulatory Framework and the Clinical Trial Process|
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 Learn about the updates since the 2013 Draft Guidance, what the changes mean, how you should prepare and more.
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.
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 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.
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 (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
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
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 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.