In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing 2. Concepts that can be used for justifying testing plans, and 3. New ideas that are not current thinking with the FDA that could change how you are testing.
Wed, Aug 21, 2013 - 01:00 pm - 02:00 pm
Epicor Software offers an on-demand webcast explaining how MDMs, tasked with complex compliance requirements, can use Enterprise Resource Planning (ERP) technology to simplify their businesses. Topics covered include using lean automated processes to streamline operations and simplify audits, future-proofing FDA compliance initiatives with agile technology, tracking Device Master Record (DMR) data and the detailed Device History Data (DHR), and approaching FDA Part 11 electronic signature software validation requirements to minimize disruptions.
Thu, Aug 1, 2013 - 02:00 pm - 03:00 pm
Available on Demand
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission (ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
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