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Upcoming Seminars

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Design & Development Essentials Workshop at MD&M EastMD&M East Conference Track
Design & Development Essentials: Bringing Your Medical Device to Market

Location: New York City, NY

Jacob K. Javits Convention Center, Room 1E14
655 W. 34th Street
New York, NY 10001
United States
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Date: June 14, 2017

Check back soon to view one of our on demand seminars.

Changes in Europe's Medical Device Regulations: Consequences for Manufacturers

8:30 A.M. - 9:30 P.M.

Peter Diesing, Ph.D.
Head of Certification
Eurofins Medical Device Testing

A European Law (MDR) revised the Medical Device Regulation in Europe completely in 2017. The MDR replaces the Medical Device Directive 93/42/EEC and creates many new requirements for manufacturers, notified bodies and competent authorities. This will influence the work of all medical device manufacturers bringing the product to the European market, whether they produce the devices in the European Union or outside the community. This presentation will give a short overview of the new regulation with the focus on the new requirements for manufacturers coming from outside the European community.

Developing Test Strategies Per the New ISO 10993-1: Current Status & Upcoming Changes

9:30 A.M. - 10:30 A.M.

Hana Hofman-Huether, Ph.D.
Head of Consulting, Toxicology
Eurofins Medical Device Testing

Evaluating and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the duration of contact between the medical device and the human body. Updates and modifications to available guidance for biological safety testing of medical devices, as described by the International Organization for Standardization (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and decreased the level of harmonization in testing requirements. However, the new ISO standard 10993-1 under development and new finalized guidance from the FDA show a similar approach – which is a shift away from routine testing-based approaches to much greater emphasis on chemical characterization. This presentation will explain the upcoming changes and their influence on the testing strategy in the future.

Chemical Characterization: The Starting Point for Biological Evaluations

10:45 A.M. - 11:45 A.M.

Hannah S. Tims, Ph.D.
Senior Chemist
Eurofins Medical Device Testing

The safety assessment of any medical device is predicated on the biological assays and chemical characterization of the device. Guidance for the performance and assessment of the chemical characterization for medical devices is described in ISO 10993, which includes recommendations for the temperature, surface area to volume ratios, and solvents to be used for the extraction.

This presentation will provide a framework for the chemical characterization of medical devices with an emphasis on extractables and leachables assessments as an important part of this process, including several case studies presenting details of extractables and leachables set-up, evaluation and implications for medical device risk assessment.

Biocompatibility Basics: Making Sense of the Annex A Matrix

1:30 P.M. - 2:30 P.M.

Odete Mendes, Ph.D.
Director of Toxicology & Pathology
Eurofins Medical Device Testing

Safety Testing of Medical Devices is an FDA requirement. Guidance regarding the scope of such testing is provided to developers by ANSI/AAMI/ISO 10993-1:2009 "Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process." Annex A of this document provides a summary matrix regarding the framework for development of a medical device risk assessment program. Testing performed to meet requirements of the Annex A matrix include cytotoxicity, sensitization and irritation studies, systemic toxicity, implantation, hemocompatibility and/or genetic toxicology. However, testing needs will vary based on nature and exposure duration. This presentation will help you navigate Annex A to ensure the success of your medical device.

Developing a Testing Plan for Medical Device Design Verification

2:30 P.M. - 3:30 P.M.

Stephen Spiegelberg, Ph.D.
Cambridge Polymer Group, Inc.

A proper verification testing plan during the design of a medical device can help streamline the design process and improve the chances for a good clinical outcome by ensuring that the individual design outputs are meeting the required design specifications. Aspects of design verification include material selection and quality acceptance criteria, device specific testing according to the key performance aspects and potential failure modes, potential aging conditions that would influence shelf life and clinical life, and tests that help define manufacturing parameters and formulation requirements. In this presentation, we outline the typical test plans that we have developed and run for clients to develop new medical devices.

Endotoxin Testing: Make Sure FDA's New Guidance Doesn't Delay Your Product Launch
3:45 P.M. - 4:45 P.M.

Tami Benjamin
Director, Microbiology
Eurofins Medical Device Testing

For years, endotoxin testing was not a consistent requirement across sterile medical devices. When it came to review of 510(K) submissions or an ongoing monitoring program a sterile device may or may not have been required to be tested for endotoxin. With the release of Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

Guidance for Industry and Food and Drug Administration Staff last March, the requirement for endotoxin testing became universal in the medical device industry. This change was not as straightforward as expected.

This workshop will provide an overview of endotoxin testing, its history, the current status and expectations of the FDA, and the establishment of current limits, as well as an interactive discussion on the new guidance, the current impact, and what may be coming.