Our Blog

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Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and...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

June 3, 2021

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...

ce marking, cer
June 3, 2021

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...

June 3, 2021

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.<...