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Design Changes and 510(k)
All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices.
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$295.00
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Maintaining A Complete Design History File
No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products.
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$295.00
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Developing a Complete Product Quality Plan
The bridge between Product Concept and Customer delivery of a product, whether it be a medical device, a component or a commercial product, is the Product Quality Plan.
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$295.00
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Quality System Records: Origin and Controls
The establishment, implementation and maintenance of a Quality Management System (QMS) requires records to provide evidence of implementation to a third party or an internal audit organization.
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$295.00
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MDD Essential Requirements: An Overview
Any medical device manufacturer seeking market clearance in the European Community must meet and follow the Medical Device Directive or MDD. Since its original release in1993 there have been several updates to this directive, the most significant of which was in September of 2007 with the release of Directive 2007/47/EC of the European Parliament and of the Council.
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$295.00
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GMP Training for Manufacturing and Administration Personnel
If you read the FDA quality system regulation clause 820. 25 (personnel) it states that: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
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$295.00
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Design History Files: Their Content and Control
After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still met, what not to have as part of the DHF and how all of the international regulations overlap in their Design History File requirements.
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$295.00
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New Requirements for the Medical Device Directive (MDD)
Back 0n September 5th 2007 the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market).
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Duration:60 Minutes
$295.00
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The FDA Electronic Submission Gateway (ESG)
With the upcoming mandate by the FDA of the use of their Electronic Medical Device Reporting System (eMDR) all medical device manufacturers will be required to create and submit MDRs via the FDA's Electronic Submission Gateway or FDA ESG.
Recorded
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Duration:60 Minutes
$295.00
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Webinar on Specification Mapping
In order for an organization to satisfy the requirements for Design Control, no matter what Quality Management System (QMS) is being followed, there needs to be traceability from the Product Requirement specification through the verification and validation processes.
Recorded
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Duration:60 Minutes
$295.00
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Introduction to ISO 14971: Risk Management
The term "Risk Based Processes" as become the latest trend in all aspects of medical device design, manufacture, test. distribution or service.
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Duration:60 Minutes
$295.00
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