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start ups, medical device, startups

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

Staying at the forefront of the medical device industry takes work - a lot..


3d printing, medical device, meddevice

The Med Device Industry (and the FDA) Embrace 3D ...

Just this week the world's first 3D-printed office opened in Dubai. It took all..

FDA, medical device, PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the..

FDA, medical device, Risk-Benefit, Patient Preference

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug..

india, labeling, medical device industry, medical device, compliance, regulatory, registration

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO..

Medical Device Report, Complaint Handling, MedWatch, Complaints, FDA, medical device, MDR, Adverse Event, Post Market Vigilance

Complaint Handling Solutions

In my last post “Who’s watching your MedWatching”, I commented on some of the..

AGILE, medical device, 62304, software development

Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process..