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As a Founder and CEO of Good Cards Medical International, I would like to welcome you to this course & learn about 'OVERVIEW of how to develop and manufacture medical devices in compliance with FDA & International regulations'. I do have 30+ years of hands on and management experience with medical device industry in USA with fortune 500 and startup companies with device development involvement and A - Z manufacturing operations management. My passion and vision is to share this knowledge and experience for the success of world wide medical device current entrepreneurs, established device company executives plus management and staff, future entrepreneurs from medical and engineering students from all disciplines and other educated beneficiaries interested in a very satisfying career in medical device industry. Medical device development and manufacturing process is extremely detailed with several regulatory requirements, but once understood it becomes easy to follow the regulations. This industry does require proper qualified support organization. In addition to the current entrepreneurs, there are multiple opportunities for educated personnel to be part of this wonderful world wide medical device industry. All educated personnel have a place in this industry. All you need is a strong desire. This course definitely gives an OVERVIEW ONLY from A - Z of what is involved. Please remember this is an OVERVIEW with several pointers towards required regulatory guidelines. This course will & should help interested beneficiaries to make proper decisions about their career and career plans. This course covers process information about how to develop medical devices from concept all the way to commercial shipment, including regulatory guidelines and requirements. It does include Medical Instrumentation and sterilized disposable devices. Given below is required key structure & development processes.Company's required organizational structure for device developmentCompany Quality Manual which includes all regulatory requirementsDevice design & design reviewsDevice design & manufacturing process development and verifications / validationsFinal regulatory compliant manufacturing production Manufacturing Quality ControlsDevice design and manufacturing documentation controls & requirements Supply chain qualifications and monitoring Regulated facilities requirements This course will benefitEntrepreneurs who should know what is required to develop and manufacture a medical device so they can confidentially know details to determine the level of funding required for a successful company.Medical students who have device ideas and aspire to be medical device Entrepreneurs & should know upfront what is involvedAll disciplines of engineering students with a strong desire for a career in medical device industryCollege students with all disciplines with a strong desire for a career in medical device industryDevice industry management personnel & executives to possess proper information so they can manage departments properly for company's success and also help them hire qualified personnel Doctors, Nurses and hospital staff to understand device development and manufacturing overview information to develop an appreciation for the devices

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