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Medical Devices

What are medical device companies doing during the lockdown?

In an attempt to flatten the curve of COVID-19, many countries implemented lockdown policies. People are allowed to leav

Medical Devices

As a Medical Device Company what can you do to help during the COVID 19 pandemic? – Here’s what –

Various benefits and flexibilities for Medical Device Manufacturers have been recently introduced. It’s impressive to

Medical Devices

FDA has stopped Inspections

FDA appreciates product firms for non-violation of its rules and regulations and continues to be in contact with firms d

Medical Devices

FDA grants the EUA authorization for Abbott RealTime SARS-CoV-2 assay – COVID – 19

As we all are aware, the FDA declared a healthcare emergency that calls for Emergency Use Authorization of medical devic

Medical Devices

Is EU-MDR coming later?

EU MDD to MDR – A major change  Medical Device Directive (MDD) which is in action now and will shortly be superse

Medical Devices

A great opportunity for companies creating monitoring devices #digitalhealth.

Importance of remote monitoring devices during COVID19 pandemic. Given that these devices allow patients to timely get t

Medical Devices

What is the classification of my software?

AI/ML changing the medical device industry Artificial Intelligence/Machine Learning based Software has revolutionized th

Medical Devices

Say goodbye to the long hours of printing – New FDA eCopy Program

An eCopy is an electronic version of a medical device submission on a CD, DVD, or flash drive, and is accompanied by a p

Medical Devices

AI/ML-based Software as a Medical Device (SaMD)-An urge for perfection

As rightly said, “Perfection is not attainable, but if we chase perfection we can catch excellence.” The urge to cre

Medical Devices

Quality Objectives – Driving Improvements

Learn about the importance of Quality Objectives (QO).

Medical Devices

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

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe.

Medical Devices

Are Breast Implants Safe?

In recent times, there has been a growing concern related to the safety of breast implants.

Medical Devices

Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD

The Software Pre-Cert Program is a pathway is more visible than the current model to assess the safety and effectiveness

Medical Devices

PATIENT PREFERENCE INFORMATION- THE TWITTER OF FDA(STREAMLINING PATIENT FEEDBACKS)

Patient inputs have always remained the core for healthcare systems, healthcare professionals and manufacturers.

Medical Devices

FDA –  Medical Devices Advisory Committee

Medical Devices Advisory Committee consists of 18 panels with a maximum of 159 standing members.

Medical Devices

IEC 60601-1 Evolution of Electrical Safety standards to match Device Development

Standards are considered as an integral part of the product design and development.

Medical Devices

De Novo paving the path  for Technological Advancements

De Novo classification is not just a device reclassification process for medical devices but it is an application also.

Medical Devices

17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)

On April 16, 2019, manufacturers of surgical mesh were ordered to stop selling their products.

Medical Devices

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.