Developing Appropriate Medical Technology

A gap exists between the practice of medicine and delivery of care on the one hand, and the development of new products and services on the other. This unique program brings together manufacturers and hospitals to discuss identifying user needs, designing for clinical experience and system safety, approaches to improving communication and research, and best practices for acquiring and adopting novel medical technologies. Registration opening soon.

A gap exists between the practice of medicine and delivery of care on the one hand, and the development of new products and services on the other. This unique program brings together manufacturers and hospitals to discuss identifying user needs, designing for clinical experience and system safety, approaches to improving communication and research, and best practices for acquiring and adopting novel medical technologies. Registration opening soon.

Continue reading

MedTech Regulatory Summit

The MedTech Regulatory Summit explores topics of urgent practical importance to manufacturers. From new US and OUS regulatory expectations to cybersecurity, current approaches to product design, and emerging trends and technologies, this two-day, triple-track summit offers a rich educational experience together with an opportunity to network and share best practices with your peers. Registration opening soon.

The MedTech Regulatory Summit explores topics of urgent practical importance to manufacturers. From new US and OUS regulatory expectations to cybersecurity, current approaches to product design, and emerging trends and technologies, this two-day, triple-track summit offers a rich educational experience together with an opportunity to network and share best practices with your peers. Registration opening soon.

Continue reading

Medical Device Recalls: Current Topics and New Initiatives

Many changes are coming that will affect risk and health hazard determination and the practical conduct of recalls and other field actions. Center and Field reorganization, new HHE procedures, UDI implementation, the rollout of tools for benefit assessment and the use of real world evidence and OUS data on device performance, Case for Quality and TPLC alignment, and more. Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls. Registration opening soon.

Many changes are coming that will affect risk and health hazard determination and the practical conduct of recalls and other field actions. Center and Field reorganization, new HHE procedures, UDI implementation, the rollout of tools for benefit assessment and the use of real world evidence and OUS data on device performance, Case for Quality and TPLC alignment, and more. Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls. Registration opening soon.

Continue reading

Medical Cybersecurity: Vulnerability and Patch Management

Dealing with medical software security threats is a problem shared by hospitals and the medical technology manufacturing industry. Designing products for updating and patching, identifying vulnerabilities, issuing and implementing patches, and responding to incidents require good communication and sharing of information. This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

Dealing with medical software security threats is a problem shared by hospitals and the medical technology manufacturing industry. Designing products for updating and patching, identifying vulnerabilities, issuing and implementing patches, and responding to incidents require good communication and sharing of information. This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

Continue reading

New Concepts in Risk Management

New regulations, standards, and concepts of risk add complexity and offer opportunities to medical product manufacturers. Run by recognized risk experts in the med tech field, this conference focuses on the practical understanding and application of current risk management principles and tools for manufacturers of medical devices, diagnostics, and combination products.

New regulations, standards, and concepts of risk add complexity and offer opportunities to medical product manufacturers. Run by recognized risk experts in the med tech field, this conference focuses on the practical understanding and application of current risk management principles and tools for manufacturers of medical devices, diagnostics, and combination products.

Continue reading

Virtual Workshop Series: FDA Submissions Strategy

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.

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.

Continue reading

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.

Continue reading

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.

Continue reading

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

Continue reading

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

Continue reading