Bullet-proof Medical Device Design
Schedule:
- 16 September 2008, 1:00 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: The creation of a new medical device that is safe and will perform as intended is the single most complex activity a company can undertake. A structured and disciplined approach to design using well thought out processes can save hundreds of thousands, if not millions, of dollars and get your product into the marketplace quickly. Additionally, well conceived designs reduce product approval costs, speed regulatory applications, reduce problems in the field, and enhance customer loyalty. This webinar will outline in a step-by-step fashion a complete medical device design process from inputs to transfer and even design change with valuable insight you can use on:
- Inherent safe design
- Human factors
- Describing intended use
- Efficient product testing
- Design verification and validation
- Efficient transfer to manufacturing
- Creating and submitting regulatory applications
- Adequate recordkeeping, and
- Demonstrating compliance during regulatory inspections or notified body assessments.
Description: Getting a design right the first time does more than save you time and money. Getting a design right the first time gets your product to the marketplace more quickly which means you are generating revenue, growing your market share and creating customer interest in your product line. This webinar will provide insight on organizing and managing your design processes for more than simple compliance, your will generate new products more quickly, with less expense and faster regulatory approvals. Do not waste time and money with the un-necessary, conducting design activities two, three or more times. Put these design process ideas to work for you.
Who should attend: This webinar is ideal for regulatory compliance and quality management staff, research and development staff and those who have to manage processes, support research and development activities, organize product testing or prepare regulatory applications as well as those who must interact with auditors and inspectors.
Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.
Expert contributor: TBA 26 Feb 2008
Registration:
$295
Registration for Sept 16th will
be set up at a later date...
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For more information or to pose a question about this webinar contact: info@raqawebinars.com (Please make sure you note the Webinar and date you are inquiring about in your email)
