This webinar will explore how a connected care solution can assist you in creating direct relationships with patients and providing them with a personalized experience that directly impacts their perceived reported outcome of the treatment. Speakers will address considerations around building a connected care solution and how you can achieve it in a very short timeframe.
CERs and PERs are frequently seen as a time-consuming hurdle medical device manufacturers have to face in order to check the compliance box for notified bodies on their go-to-market path. This webinar will look at how manufacturers are keeping up with the unprecedented pace evidence-based research is being produced, ways to optimize manual literature review processes and shifting the CER/PER submission mindset from hurdle to opportunity.
Join us for a panel discussion on the EU MDR lessons learned since the May 26th deadline requiring all new medical devices to meet Regulation (EU) 2017/745. The webinar will cover the key concerns, challenges and common non-conformities that manufacturers, consultants and notified bodies are seeing from the application stage to final approval.
Wearable medical devices market growth is attributed to a growing need for cost-effective diagnosis and treatments. The convenience and real-time data that wearable devices provide (i.e., fitness trackers, ECG monitors, blood pressure monitors, wearable biosensors, smart glasses, hearables, etc.) allows many medical industry, insurers, providers, and technology companies to incorporate them into their processes. These advances can offer remote healthcare that is safer, timelier and more convenient as it removes the need for the patient to be continuously transferred to the medical center. The presentation will outline History of Wearable Devices; Recent development for wearable devices; eHealth and mHealth devices; Definitions; Regulatory requirements, concerns, and recommendations; and Forecast for growth.
MedTech organizations are still in the window to prepare for the evolutionary changes as a result of the COVID-19 pandemic, but soon businesses will either be at the forefront of these changes, embracing them or they will get comfortable, negligent, and fall behind. From improving deal time to addressing revenue leakage, medtech organizations must turn to technology in order to prepare the business for the future.
There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently? Join us for a behind-the-scenes look at how one company is managing change within their organization.
The COVID-19 pandemic has disrupted global supply chains on a monumental scale, rushing all MD&D manufacturers to quickly re-adapt and respond to new challenging market conditions. The program is designed to inspire discussion among cross-functional teams across your organization, taking time to debrief and compare notes after the webinar.
With the application date fast approaching, gain insights into the new MDR requirements. Following the webinar, you will be better prepared to meet the increased requirements that have been placed on medical device manufactures. You will gain an understanding of your next steps, whether it is additional MDR transition training, or what to discuss with your notified body.
This risk management training webinar provides an overview of changes to the risk management standard (ISO 14971:2019), the associated guidance documents (ISO/TR 24971:2020), and the new European Requirements as outlined in Annex I of Regulation (EU) 2017/745. During this webinar you will learn the difference between a process risk analysis and the risk management activities associated with design of medical devices. You will also learn how to create a risk management plan.
EU IVDR implementation is not merely a question of changing a few SOPs. It requires a portfolio review of legacy products and substantial changes from the top down in organizational structure and processes. Learn from experts who have already gone through IVDR implementation, know where the greatest costs and stumbling blocks lie, and offer strategies for effective project management.