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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 inhibiting patient access, of software technologies which are being used as Medical Devices. The U.S. Food and Drug Administration (FDA) introduced Software Precertification program to address problems…

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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 associated with these implants, especially those are textured The U.S. Food and Drug Administration had warned women since 2011 about the risk associated with the implants…

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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EU MDD to MDR – A major change  Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and implemented by the industry for over several decades.  The advent of new rules, European Medical Device Regulations (EU MDR), is a major change to…

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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 keep the continuity of the sale in Europe. It’s certainly wise for companies to invest the time in understanding the differences between…

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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 Clinical Evaluation Report. A Clinical Evaluation Report (CER) documents the clinical data of a medical device and helps in…

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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 MEDDEV has resulted in difficulty in getting a CE or the CE of an existing product going on hold. Common pitfalls…

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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. SaMD is software which on its own is a device employed for a medical purpose. The International Medical Device Regulators Forum (IMDRF)…

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