You are here:
Medical device development end to end

Medical Device Development Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessment and feasibility analysis, to design development verification and validation, leading to activities for the pre-launch preparation, and ultimately the product launch, market commercialization, and post-market surveillance. Medical device development…

Read article
Business People Analyzing Statistics Financial Concept
FDA – Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory committee protects and promotes public health while meeting the requirements established in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the…

Read article
Is EU-MDR coming later?

EU MDD to MDR – A major change  Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and implemented by the industry for over several decades.  The advent of new rules, European Medical Device Regulations (EU MDR), is a major change to…

Read article
Know the differences for proactive planning – MDD to MDR

The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical device companies will be eventually expected to comply with it in order to keep the continuity of the sale in Europe. It’s certainly wise for companies to invest the time in understanding the differences between…

Read article