PATIENT PREFERENCE INFORMATION- THE TWITTER OF FDA (STREAMLINING PATIENT FEEDBACKS)
Patient inputs have always remained the core for healthcare systems, healthcare professionals & medical equipment manufacturers. Especially in the age of social…
Read article
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…
Read article
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…
Read article
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…
Read article
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EU MDD to MDR – A major change Medical Device Directive (MDD) which is in action now and will shortly be superseded…
Read article
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…
Read article
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…
Read article
Make yourself aware of the importance of keeping all design documents tucked in!
Behind every innovation, there are years of hard work, passion, and perseverance. A medical device based on innovation, meticulous planning, and excellent…
Read article
Comprehensive CER – A key component to CE Marking
Applying for a CE Marking or have one already? In both the cases, CER would be created or updated per MEDDEV 2.7/1…
Read article
