MedTech Import/Export: Regulations, Procedures, Best Practices

Rules and procedures for import and export of medical devices are growing more so with new rules and with changes in international trade agreements. Customs and FDA have been requesting more information and conducting more inspections and examinations than before. Mistakes in procedures or documentation can lead to withheld or seized shipments and consequent financial lost to U.S. and foreign manufacturers, suppliers, and brokers. This one-day program with speakers from government, industry, and consulting firms will cover the laws and regulations, recent changes, procedures, best practices, and common mistakes.

Rules and procedures for import and export of medical devices are growing more so with new rules and with changes in international trade agreements. Customs and FDA have been requesting more information and conducting more inspections and examinations than before. Mistakes in procedures or documentation can lead to withheld or seized shipments and consequent financial lost to U.S. and foreign manufacturers, suppliers, and brokers. This one-day program with speakers from government, industry, and consulting firms will cover the laws and regulations, recent changes, procedures, best practices, and common mistakes.

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MedTech M&A: Regulatory & Quality Due Diligence

The medical technology industry is witnessing a growing number of mergers and acquisitions, and poses a unique set of challenges when it comes to due diligence. This interactive conference, mixing didactic sessions with discussion and case studies, is led by senior industry professionals who have gone through mergers and acquisitions and seen both the good and the bad, focuses on those issues unique to medical technology companies.

The medical technology industry is witnessing a growing number of mergers and acquisitions, and poses a unique set of challenges when it comes to due diligence. This interactive conference, mixing didactic sessions with discussion and case studies, is led by senior industry professionals who have gone through mergers and acquisitions and seen both the good and the bad, focuses on those issues unique to medical technology companies.

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Medical Device Process Validation (Virtual Conference)

Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA. This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.

Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA. This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.

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EU MDR Implementation Strategies Workshop

The regulations are there for anyone to read, but even the largest, best-prepared companies have large teams struggling with implementation. There is no easy answer, but we are all in this together, and by pooling thoughts and solutions can expedite the process for everyone. This two-day workshop convenes experts from major companies, notified bodies, and consulting firms to share strategies, procedures, experiences, and challenges.

The regulations are there for anyone to read, but even the largest, best-prepared companies have large teams struggling with implementation. There is no easy answer, but we are all in this together, and by pooling thoughts and solutions can expedite the process for everyone. This two-day workshop convenes experts from major companies, notified bodies, and consulting firms to share strategies, procedures, experiences, and challenges.

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How to Mitigate Risks through the Life Science Supply Chain Webinar

Recorded November 10, 2017, this essential webinar will help you to discover how new technologies draw on the power of the cloud and utilize the latest integration capabilities, including an inside glance at how Kimberly-Clark is making use of these technologies. Sponsored by Verse.

Recorded November 10, 2017, this essential webinar will help you to discover how new technologies draw on the power of the cloud and utilize the latest integration capabilities, including an inside glance at how Kimberly-Clark is making use of these technologies. Sponsored by Verse.

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Applying Risk-based Thinking in Medical Devices Webinar

Recorded October 31, 2017, this webinar explored the concept of risk-based thinking, what it means for the Medical Device industry, and how you can leverage these concepts into your operations. Sponsored by Verse.

Recorded October 31, 2017, this webinar explored the concept of risk-based thinking, what it means for the Medical Device industry, and how you can leverage these concepts into your operations. Sponsored by Verse.

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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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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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MedTech Product Development: Getting the Right Products to Market Sooner

Product development is the key to a vital and profitable medical technology industry, but the process poses many challenges, according to a recent reader survey conducted by MedTech Intelligence. This webinar features industry experts in a roundtable discussion addressing key issues in product development. Recorded June 9, 2016.

Product development is the key to a vital and profitable medical technology industry, but the process poses many challenges, according to a recent reader survey conducted by MedTech Intelligence. This webinar features industry experts in a roundtable discussion addressing key issues in product development. Recorded June 9, 2016.

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