Blogs
Medical Device Incident and Adverse E…
Prior preparation is necessary for an immediate investigation of incidents once they occur. This is n…
USA and EUROPE Looking Ahead to 2020
USA – Food and Drug Administration (FDA)
The Center for Drug Evaluation and Research (CDER) contin…
TGA: Regulatory Impact Statement R…
Technology changes have the potential to deliver significant advantages and opportunities to Australi…
Danish Medicines Agency Recommended N…
Danish Medicines Agency recommended a new regulation on medical devices (MDR 2017/745) is effective f…
TMDA Released Guidance on the Import …
Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the princi…
FDA Issues Guidances on Dual 510(k) a…
The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual …
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