Quality Objectives – Driving Improvements

Learn about the importance of Quality Objectives (QO), how are they important for a medical device company’s Quality Systems, and how to draft accurate Quality Objectives intended to drive impro...

De Novo – A Propeller for Innovation!

While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never do they want to decelerate the pace at which new techno...

510(k) Premarket Notification – A Passport for Market Entry

There are some important requirements for establishing SE. The flowchart below lays out, at a high level, the decision making process that the FDA employs to come to a decision of SE or NSE (Non...

Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour

In the recent two decades, Cardiovascular Research has grown into a leading field. According to the “Heart Disease and Stroke Statistics — 2015 Update” released by the American Health Associatio...

Are you making the right claims on your cosmetic products?

Knowingly or unknowingly, cosmetic products have become an indispensable part of our daily lives. Majority of women wear some kind of cosmetic product like eye and facial makeup, skin moisturize...

Can Wearable Devices Compete With Hospital Capital Equipments?

Hospital Medical equipment is designed to aid in the treatment, monitoring and diagnosis of medical conditions. The Hospital equipments include, but are not limited to medical monitors like EEG,...

5 tips for a successful 510(k) submission

A medical device, before being released into the interstate US commerce, needs to pass the fastidious scrutiny of the FDA. Apart from the devices in class III, which require a PMA, for few of th...

Refuse to Accept Policy

Refuse To Accept outlines the basis on which the FDA decides whether a 510(k) submission meets required acceptability standards and if it should be further considered for a substantive review. I...

Intended use and indications for use

There is always some uncertainty when it comes to distinguishing between intended use and indications for use. Most people often interchange the terms during usage. We have made a concise table ...

eCopy

eCopy(electronic copy) is done as a part of submission package for CDRH (Centre for Devices and Radiological Health).

It is an essential part of:

510(k)De novoPMA (Pre market appro...