Author: Criterion Edge Writers
Staying current with national and international regulatory updates is a constant challenge for those in the medical device industry. Medtech Insight, already known for their website that provides up-to-date information with current trends and market data, has launched a new tool, the Global Medtech Guidance Tracker. This useful addition “comprehensively tracks regulatory guidance documents issued by medtech authorities from around the globe,” providing one location to read and search worldwide regulatory updates.
The tracker is continuously updated, with new documents added every month. It organizes salient data by country, organization, and status (draft or final). Links in the tracker provide access to data, documents, and changes happening in real time. The tracker allows you to search data and original documents from 22 national and international regulatory organizations, including the Health Products Regulatory Authority (HPRA), European Commission (EC), and China FDA (CFDA).
The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What do they entail, and why are there problems in understanding what will be required? Consultant Sarah Sorrel offers insights in an interview with Medtech Insight.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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