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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EU MDD to MDR – A major change  Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and implemented by the industry for over several decades.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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Quality Objectives – Driving Improvements

Learn about the importance of Quality Objectives (QO), how are they important for a medical device company’s Quality Systems, and how to draft accurate Quality Objectives intended to drive improvements, customer satisfaction, and product quality, while being in line with the Quality Policy (QP) of the Organization. What are Quality Objectives? Quality Objectives are a…

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De Novo – A Propeller for Innovation!

While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never do they want to decelerate the pace at which new technologies are coming to the market. Along these lines is the FDA’s De Novo classification process which is used to classify medical devices…

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510(k) Premarket Notification – A Passport for Market Entry

There are some important requirements for establishing SE. The flowchart below lays out, at a high level, the decision making process that the FDA employs to come to a decision of SE or NSE (Non Substantially Equivalent). Every person who wants to market a medical device in the United States, be it a Class I,…

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