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Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and...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

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 execution goes a long way in changing t...

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 Revision 4 (June 2016). Non compliance to this new revision of the MEDDE...

Software as Medical Device (SaMD)

The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices.<...