Learn OVERVIEW of how to develop and manufacture a medical device in compliance with FDA and International regulations
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’.
What you’ll learn
- OVERVIEW OF ‘HOW TO DEVELOP (FROM CONCEPT ALL THE WAY TO COMMERCIAL SHIPMENT) MEDICAL DEVICES AND MANUFATURE IN COMPLIANCE WITH FDA & INTERNATIONAL REGULATIONS’.
- UNDERSTADING OF FDA’S ONLINE ALL AVAILABLE GUIDELINE PUBLICATIONS & UPDATES RELATED TO MEDICAL DEVICE REGULATORY COMPLIANCE AND APPROVALS AND RELATED TOPICS.
- DEVICE DESIGN VERIFICATION & VALIDATIONS, DESIGN PROCESS, MFG. PROCESS V & V, QUALITY, DOCUMENTATION, SUPPLY CHAIN CONTROLS & OTHER REGULATORY REQUIREMENTS.
- HOW TO UNDERSTAND & MANEUVER USA FDA WEBSITE & SEVERAL HYPERLINKS RELATED TO DEVICE DEVELOPMENT DESIGN, MFG. PROCESS & QUALITY & OTHER REGULATION REQUIREMENTS.
- 1. FDA DEVICE CLASSIFICATIONS CLASS I, CLASS II AND CLASS III ………. 2. FDA AUDITS AND WHAT ARE 483 NOTIFICATIONS ……… 3. FDA RECALL CIRCUMSTANCES.
- FINALLY, REQUIRED ORGANIZATIONAL STRUCTURE AND PERSONNEL REGULATORY TRAINING REQUIRED TO RUN A MEDICAL DEVICE COMPANY..
Course Content
- THIS COVERS LECTURE 1 (VIDEO SLIDES 1-12) AND LECTURE 2 (VIDEO SLIDES 13-48) –> 2 lectures • 2min.
- VIDEO SECTION 3 (SLIDES 49-88) LISTS FDA & OTHER WEBSITES & HYPERLINKS WITH IDs –> 1 lecture • 1min.
- VIDEO SECTION 4 (SLIDES 89 -101) FOUNDER’S USA DEVICE EXP. AND FDA RECALL INFO –> 1 lecture • 1min.
- 2 1/2 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION W/CLICKABLE LINKS –> 2 lectures • 2hr 43min.
Requirements
- 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 managment 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 desciplines 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 development
- Company Quality Manual which includes all regulatory requirements
- Device design & design reviews
- Device design & manufacturing process development and verifications / validations
- Final regulatory compliant manfucaturing production
- Manufacturing Quality Controls
- Device design and manfucaturing documentation controls & requirements
- Supply chain qualifications and monitoring
- Regulated facilities requirements
- This course will benefit
- Entrepreneurs 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 involved
- All desciplines of engineering students with a strong desire for a career in medical device industry
- College students with all desciplines with a strong desire for a career in medical device industry
- Device 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