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…
Read articleTHE 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…
Read articleMake 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…
Read articleComprehensive 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…
Read articleSoftware 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…
Read articleQuality 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…
Read articleDe 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…
Read article510(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…
Read articleBreakthroughs 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 —…
Read article