FDA Submissions Strategy

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

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510(k) and de Novo Pathways to Market

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

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Making UDI Tracking Part of Your Systems

Medical device manufacturers need better systems to be able to comply with new regulations whether you’re talking about ERP or QMS validation for the FDA (i.e. 21 CRP Part 11, and Part 820), UDI traceability, high-read-rate bar codes, or product liability insurance. All these areas carry enormous costs and risks if done incorrectly. Recorded September 26, 2017. Sponsored by Southeast Computer Solutions

Medical device manufacturers need better systems to be able to comply with new regulations whether you’re talking about ERP or QMS validation for the FDA (i.e. 21 CRP Part 11, and Part 820), UDI traceability, high-read-rate bar codes, or product liability insurance. All these areas carry enormous costs and risks if done incorrectly. Recorded September 26, 2017. Sponsored by Southeast Computer Solutions

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PMA Submissions Workshop

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

Premarket Submissions Workshop Series – A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

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HHE, Benefit-Risk, and Recalls plus Global Recalls Workshop

Recorded May 17-19, 2017, The fifth annual MedTech Intelligence medical device recalls conference featured senior level CDRH and industry speakers for in-depth discussions of a range of new topics, including new FDA initiatives, the practical application of benefit-risk to recalls, the use of decision analysis, the Risk Assessment Form, clinical versus engineering perspectives on risk, procedures and expectations for recall termination, and hospital recommendations for more effective recall communications and processes. Price: $1,495

Recorded May 17-19, 2017, The fifth annual MedTech Intelligence medical device recalls conference featured senior level CDRH and industry speakers for in-depth discussions of a range of new topics, including new FDA initiatives, the practical application of benefit-risk to recalls, the use of decision analysis, the Risk Assessment Form, clinical versus engineering perspectives on risk, procedures and expectations for recall termination, and hospital recommendations for more effective recall communications and processes. Price: $1,495

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Risk Management Outside Your Four Walls: Implementing Risk Strategies for the Supply Chain

Recorded: December 13, 2016. The key becomes one of risk-based thinking in supply chain quality. In this webinar, we will look at the various elements that focus on the ability to connect with the supply chain, while maintaining an acceptable level of regulatory compliance. Sponsored by Verse Solutions.

Recorded: December 13, 2016. The key becomes one of risk-based thinking in supply chain quality. In this webinar, we will look at the various elements that focus on the ability to connect with the supply chain, while maintaining an acceptable level of regulatory compliance. Sponsored by Verse Solutions.

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Medical Device Cybersecurity

Recorded March 23-24, 2017 – Medical device cybersecurity is a looming threat that often appears in the news. Unlike most cybersecurity programs that merely raise the dreaded spectre of what may go wrong, this highly interactive workshop focuses on practical steps that manufacturers can take. How can you design and test secure products, monitor safeguards for effectiveness, and what emergency procedures should be in place to minimize damage and liability in the event of a breach? Price $995.00

Recorded March 23-24, 2017 – Medical device cybersecurity is a looming threat that often appears in the news. Unlike most cybersecurity programs that merely raise the dreaded spectre of what may go wrong, this highly interactive workshop focuses on practical steps that manufacturers can take. How can you design and test secure products, monitor safeguards for effectiveness, and what emergency procedures should be in place to minimize damage and liability in the event of a breach? Price $995.00

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Medical Device Software

Recorded: March 21 & 22, 2017 – Software is ubiquitous in the world of medical technology, and is the source of many problems and enforcement actions. For the regulatory, quality, and product development professionals who manage and oversee software inside of or connecting their products, it can be difficult to interact most productively with IT professionals. This interactive workshop is specifically designed to help non-software professionals better understand what to look for and beware of, what questions to ask and decisions to make, and how to monitor products and systems for potential issues. Price: $995.00

Recorded: March 21 & 22, 2017 – Software is ubiquitous in the world of medical technology, and is the source of many problems and enforcement actions. For the regulatory, quality, and product development professionals who manage and oversee software inside of or connecting their products, it can be difficult to interact most productively with IT professionals. This interactive workshop is specifically designed to help non-software professionals better understand what to look for and beware of, what questions to ask and decisions to make, and how to monitor products and systems for potential issues. Price: $995.00

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FDA Advisory Panels

Recorded March 1-2, 2017 – “Going to panel” can make or break a new technology or company. An FDA Advisory Committee meeting is the culmination of much time, effort, and money. The outcome can determine whether a product makes its way to market or not. Knowing the procedures, learning from past experience, and understanding the participants and attendees and their roles, biases, and objectives are all critically important in helping a company most effectively prepare the most persuasive case while providing for possible contingencies. In this unique workshop, experienced professionals share experiences and best practices for preparing for and conducting a medical device panel meeting. Price $995.00

Recorded March 1-2, 2017 – “Going to panel” can make or break a new technology or company. An FDA Advisory Committee meeting is the culmination of much time, effort, and money. The outcome can determine whether a product makes its way to market or not. Knowing the procedures, learning from past experience, and understanding the participants and attendees and their roles, biases, and objectives are all critically important in helping a company most effectively prepare the most persuasive case while providing for possible contingencies. In this unique workshop, experienced professionals share experiences and best practices for preparing for and conducting a medical device panel meeting. Price $995.00

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Process and Test Method Validation for Medical Devices

This program brings together government, industry, and other experts to discuss the challenges of Production and Process Validation and Test Method Validation and practical approaches to meeting them. Recorded February 2017. Price: $995.00

This program brings together government, industry, and other experts to discuss the challenges of Production and Process Validation and Test Method Validation and practical approaches to meeting them. Recorded February 2017. Price: $995.00

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