Medical Device Recalls: Procedures & Best Practices – San Francisco, CA

Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line. This conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.

Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line. This conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.

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Medical Device Statistics for Non-Statisticians

The QSR and other regulations and standards require statistical analysis of manufacturing processes and product performance. You do not need to become a statistician to comprehend and oversee the appropriate use of statistical methods in medical device development, testing, manufacturing, and postmarket surveillance. This course is specifically designed for non-statisticians. No prior statistical training is required.

The QSR and other regulations and standards require statistical analysis of manufacturing processes and product performance. You do not need to become a statistician to comprehend and oversee the appropriate use of statistical methods in medical device development, testing, manufacturing, and postmarket surveillance. This course is specifically designed for non-statisticians. No prior statistical training is required.

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Practical Risk Management

It is increasingly difficult for medtech manufacturers to comply with the growing array of existing and new U.S. and OUS regulations, guidances, and standards, and to understand the tools & best practices for the effective application of risk principles throughout the product life cycle. This conference focuses on the practical understanding and application of risk management for manufacturers of medical devices, diagnostics, and combination products.

It is increasingly difficult for medtech manufacturers to comply with the growing array of existing and new U.S. and OUS regulations, guidances, and standards, and to understand the tools & best practices for the effective application of risk principles throughout the product life cycle. This conference focuses on the practical understanding and application of risk management for manufacturers of medical devices, diagnostics, and combination products.

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Medical Device Recalls: Procedures and Best Practices – Coral Gables, FL

Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line. This conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.

Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line. This conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.

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Medical Device Cybersecurity Workshop

Cybersecurity for medical devices is mandatory: FDA requires precautions both pre- and post-market and in remediation of legacy products. Hospitals factor cybersecurity into purchasing decisions. This workshop covers requirements and standards, design and testing methods, integration of cybersecurity into a QMS, legacy product remediation, post-market surveillance, and response in the event of a breach.

Cybersecurity for medical devices is mandatory: FDA requires precautions both pre- and post-market and in remediation of legacy products. Hospitals factor cybersecurity into purchasing decisions. This workshop covers requirements and standards, design and testing methods, integration of cybersecurity into a QMS, legacy product remediation, post-market surveillance, and response in the event of a breach.

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Premarket Submissions Workshop Series – Schaumburg, IL

Join us in Menlo Park, CA for three one-day workshops about the premarket submission process. November 29: 510(k) Premarket Notification, November 30: PMA Submissions, December 1: FDA Submissions Strategy. There is a separate fee for each workshop.

Join us in Menlo Park, CA for three one-day workshops about the premarket submission process. November 29: 510(k) Premarket Notification, November 30: PMA Submissions, December 1: FDA Submissions Strategy. There is a separate fee for each workshop.

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Premarket Submissions Workshop Series – Menlo Park, CA

Join us in Menlo Park, CA for three one-day workshops about the premarket submission process. October 23: 510(k) Premarket Notification, October 24: PMA Submissions, October 25: FDA Submissions Strategy. There is a separate fee for each workshop.

Join us in Menlo Park, CA for three one-day workshops about the premarket submission process. October 23: 510(k) Premarket Notification, October 24: PMA Submissions, October 25: FDA Submissions Strategy. There is a separate fee for each workshop.

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The New EU Medical Device & IVD Regulations

In this highly interactive virtual conference, the two largest and most experienced notified bodies, together with experts from companies well advanced in planning for the upcoming changes, present the issues and requirements, experience, and best practices for efficient compliance and remediation.

In this highly interactive virtual conference, the two largest and most experienced notified bodies, together with experts from companies well advanced in planning for the upcoming changes, present the issues and requirements, experience, and best practices for efficient compliance and remediation.

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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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China: The MedTech Market

China has tremendous medtech opportunities, including selling products, sourcing and local manufacturing. Succeeding, however, is not easy. This conference will review best business strategies for success and pitfalls to avoid. Topics will include: assessing the market opportunity, optimal business strategies, best procedures for exporting and distributing medtech products, strategies for sourcing components, key factors in setting up local manufacturing, protecting IP and best approaches for registering products with the CFDA.

China has tremendous medtech opportunities, including selling products, sourcing and local manufacturing. Succeeding, however, is not easy. This conference will review best business strategies for success and pitfalls to avoid. Topics will include: assessing the market opportunity, optimal business strategies, best procedures for exporting and distributing medtech products, strategies for sourcing components, key factors in setting up local manufacturing, protecting IP and best approaches for registering products with the CFDA.

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