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…
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THE A-Z OF CLINICAL EVALUATION REPORT
Ever wondered if the product that you are using is safe? Ever wondered how is the safety assured? Ever wondered where do…
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Make yourself aware of the importance of keeping all design documents tucked in!
Behind every innovation, there are years of hard work, passion, and perseverance. A medical device based on innovation, meticulous planning, and excellent…
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Comprehensive CER – A key component to CE Marking
Applying for a CE Marking or have one already? In both the cases, CER would be created or updated per MEDDEV 2.7/1…
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Software as Medical Device (SaMD)
The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical…
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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…
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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…
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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…
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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 —…
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