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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.

Medical 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...”

Medical Devices

Modernization of 510(k) – A major milestone to safer and better healthcare

More than 190,000 distinct medical devices are regulated by the FDA!

Medical Devices

De Novo – A Propeller for Innovation!

"For good ideas and true innovation, you need human interaction, conflict, argument, and debate."

Medical Devices

Software as Medical Device (SaMD)

Software has become an integral part of almost all facets of life including the healthcare and medical field.

Medical Devices

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.

Medical Devices

Comprehensive CER – A key component to CE Marking

Applying for a CE Marking or have one already?

Medical Devices

Breath Analyzers – As Diagnostic Tools

Breath Analyzers are one of the modern innovative devices that have emerged with the intent to improve healthcare.

Medical Devices

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.

Medical Devices

THE A-Z OF CLINICAL EVALUATION REPORT

Ever wondered if the product that you are using is safe?

Medical Devices

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 ...

Medical Devices

IMPORT/EXPORT-U S: Expand your boundaries

Globalization and international trade has drastically changed the face of the world.

Medical Devices

DOCUMENT CONTROL SYSTEM:The CORE of Quality Management System

Has managing documents always been a tedious and time consuming task for you?

Medical Devices

Quality Sytems: Facilitating continuous improvement!

What is continuous improvement and how can we achieve it?

Medical Devices

Testing

Testing is to ascertain the working of the device as per its intended use, and to ensure its safety and effectiveness.

Medical Devices

How we differ?

A Regulatory Firm that stands out!

Medical Devices

Product Development

Product Development is unique, constantly changing, and very crucial.

Medical Devices

Labels

A label is the display of information about a particular product on its packaging or on itself, which may be in written

Medical Devices

Postmarket Surveillance: An inescapable sound of noice

Are you a Medical Device Manufacturer? An employee of a medical device company?

Medical Devices

Regulatory Submissions

Success is sweet, but its secret is sweat