Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom go any further. Oftentimes, what information is provided in a standard is more descriptive rather than prescriptive, which is necessary in a national or international standard.
Thu, Oct 10, 2013 - 11:00 am - 12:00 pm
While Process Improvement is described by many Med-Tech Executives as an “imperative to survival,” the benefits of these initiatives have eluded most in the Medical Technology sector. The majority of Med-Tech companies are still chasing “defects.”
Tue, Oct 8, 2013 - 11:00 am
Optimal Catheter Design: Making the Smart Choices When Selecting Materials and Manufacturing Processes
Today’s sophisticated catheters have become modern marvels of advanced design and polymer technology. This information-filled presentation will help you make the right choices of materials and production processes to achieve cost and performance objectives of a catheter-based project while avoiding the pitfall of over engineering. Topics include cost/benefit trade-offs offered by different manufacturing technologies and the integration of advanced polymers’ characteristics into the design of next-gen catheters.
Thu, Sep 26, 2013 - 02:00 pm - 03:00 pm
New Advances in Conformal Coating Technologies for Medical Devices: An Overview of Parylene Conformal Coatings, Including New Antimicrobial Technology
For over 30 years, the medical device industry has realized the benefits of utilizing conformal coatings, including biocompatibility, electrical, chemical and moisture barrier properties, frictional properties, and overall improvement of substrate properties. This webinar will discuss the variants of Parylene, their unique and highly useful attributes, their application processes and examples of how Parylenes have solved device challenges. It will also review a new antimicrobial Parylene technology that effectively reduces (greater than 5 Log) harmful microorganisms on coated medical devices.
Wed, Sep 25, 2013 - 02:00 pm - 03:00 pm
Understanding the nature of the microorganisms in manufacturing environments and on or in products is a vital step in medical device and pharmaceutical processing. In this webinar we will discuss the compendial requirements and recommendations regarding:The importance of microbial identification in an environmental monitoring program.How microbial identification is an important tool with gamma sterilized medical device validations in understanding a product bioburden baseline, in defining product families and in determining the frequency of dose audits.How microbial identification can be critical in investigations of environmental excursions, bioburden spikes, sterility failures, Biological indicator (BI) testing and Microbial Limits screening.Information will be included on microbial identification testing at Nelson Labs, from the benefit of sub-culturing organisms to the importance of a Gram stain as part of a polyphasic approach to identification.
Thu, Aug 29, 2013 - 11:00 am - 11:45 am
In this 20 minute webinar, Tony Holtz lays out basic design “rules” for successful plastic injection molding. As with many of life’s rules, some of these can be bent if absolutely necessary. But bending rules has costs and consequences, and this webinar addresses ways to work with the process and within its guidelines to make the most of injection molding’s flexibility and enormous potential.
Wed, Aug 28, 2013 (All day)
Available on Demand
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).
Wed, Jul 20, 2011 - 01:47 pm - Sun, Jul 5, 2015 - 01:47 pm
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- Expanding Opportunities with a Simplified Supply Chain - Supplier Resource
- Microfluidics—A Powerful Technology for Diagnostic and Medical Product Development - Video