Our Blog

June 3, 2021

Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices?  We und...

June 3, 2021

FDA – Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory committee protects and...

June 3, 2021

IMPORT/EXPORT-U S: Expand your boundaries

Globalization and international trade has drastically changed the face of the world. In the last couple of years, communication and trade has bloomed between the developed and developing countri...

June 3, 2021

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

Patient inputs have always remained the core for healthcare systems, healthcare professionals and medical equipment manufacturers. Especially in the age of social media, the user or the patient ...

June 3, 2021

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 record and she received several bitcoins demands. Suddenly her desktop was filled wit...

June 3, 2021

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

The Software Precertification (Pre-Cert) Program is a pathway that comprises a regulatory model which is more visible than the current model to assess the safety and effectiveness, without inhib...

June 3, 2021

Are Breast Implants Safe?

In recent times, there has been a growing concern related to the safety of breast implants. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is one of the major pathologies as...

June 3, 2021

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Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and...

June 3, 2021

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 will be eventually expected to comply with it in order to...

June 3, 2021

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 all the complaints and feedback go? A simple answer to all these is a Cli...