Access to De Novo Summaries – A treasure for manufacturers
The De Novo pathway by the US FDA, is a risk-based classification process to classify novel medical devices.
Addressing Duodenoscope contamination – An FDA Initiative
FDA is collaborating with CDC and HICPAC to seek inputs to improve the efficacy and safety of reprocessed devices.
Is new always good?The Science behind Product Sustenance
“The advance of technology is based on making it fit in so that you don’t really even notice it...”
Modernization of 510(k) – A major milestone to safer and better healthcare
More than 190,000 distinct medical devices are regulated by the FDA!
De Novo – A Propeller for Innovation!
"For good ideas and true innovation, you need human interaction, conflict, argument, and debate."
Software as Medical Device (SaMD)
Software has become an integral part of almost all facets of life including the healthcare and medical field.
Wearable ECG Monitor: Regulations, Standards and Guidance
The wearable ECG monitor band typically has 3 electrodes and a user interface with a button to switch on the system.
Comprehensive CER – A key component to CE Marking
Applying for a CE Marking or have one already?
Breath Analyzers – As Diagnostic Tools
Breath Analyzers are one of the modern innovative devices that have emerged with the intent to improve healthcare.
Make yourself aware about the importance of keeping all design documents tucked in!
Behind every innovation, there are years of hard work, passion, and perseverance.
THE A-Z OF CLINICAL EVALUATION REPORT
Ever wondered if the product that you are using is safe?
CYBERSECURITY – Don’t Neglect. An increasing threat of the modern world.
Rita, a nurse at PCN Health Care Hospital logged into her system on a Monday morning to retrieve a patient’s ...
IMPORT/EXPORT-U S: Expand your boundaries
Globalization and international trade has drastically changed the face of the world.
DOCUMENT CONTROL SYSTEM:The CORE of Quality Management System
Has managing documents always been a tedious and time consuming task for you?
Quality Sytems: Facilitating continuous improvement!
What is continuous improvement and how can we achieve it?
Testing
Testing is to ascertain the working of the device as per its intended use, and to ensure its safety and effectiveness.
Product Development
Product Development is unique, constantly changing, and very crucial.
Labels
A label is the display of information about a particular product on its packaging or on itself, which may be in written
Postmarket Surveillance: An inescapable sound of noice
Are you a Medical Device Manufacturer? An employee of a medical device company?
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