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Which medical devices fall under the EU MDR scope?

Which medical devices fall under the EU MDR scope?

By when do I need to update the Clinical Evaluation Report?

By when do I need to update the Clinical Evaluation Report?

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released today a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Final EU MDR, IVDR Texts Published

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published today in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May.

Let's Get you Ready for your Clinical Trial | Webinar | US perspective

Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise. Download this 30 min. webinar and increase your chances of successfully launching your medical device.

5 tips for post-market medical device compliance

Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting you to follow through and have effective procedures.

Regulatory Challenges of Software as a Medical Device

The healthcare industry is witnessing many changes in this digital era. A recent revolutionary development in digital health technology is software that can perform complex medical functions - software as a medical device (SaMD). Download this white paper and discover why implementing a regulatory strategy early in the development will go far in bringing you closer to successful market access of your SaMD.