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Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and...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