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Post-Market Clinical Follow-up or PMCF refers to activities that help provide data, documentation, and evidence regarding a medical device’s safety or performance. PMCF is one component of post-market surveillance (PMS) activities for medical devices. The purpose of PMCF is to confirm the clinical performance and safety of the device in real-world use and help manufacturers manage acceptable risk. PMCF and PMS data safety and performance data collected from real-world device usage are expected to feed back into a re-evaluation of Risk determination over the life cycle of the device.

The Food and Drug Administration (FDA) drug approval process is a core component of drug discovery in the United States. Whether it’s a cancer drug or other medication, medical treatments in the U.S. have to go through a specific process to make sure they’re safe and effective before being released to the public. The FDA oversees the process from start to finish and even after approval. Only after a thorough analysis by a team of CDER scientists (Center for Drug Evaluation and Research) can new medicines and treatments be approved for sale in the United States. They review each drug closely using an independent team of professionals and scientists who evaluate the safety, efficacy, and labeling of the drug product.

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. Some changes may be relatively minor, such as the change in terminology from Essential Requirements to General Safety and Performance Requirements, while others may have a significant impact on the need for clinical evidence and evaluation, leading to modifications in CER processes and collection of additional data from clinical investigations to support a product undergoing review along with an improved quality management system.

A Clinical Evaluation is used to demonstrate a medical device’s safety and performance and its overall positive benefit-to-risk ratio by analyzing clinical data. Clinical Evaluation is part of a series of guidelines dealing with questions of application of EU-Directives on Medical Devices.

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In light of COVID-19, the global medical device outsourcing market reached $99.9 billion in 2020. The healthcare and medical device manufacturing industries are constantly growing to meet new demands. Unfortunately, healthcare reform, digital transformation, and other issues can affect medical device sales. Are you struggling through the device design, manufacturing, and sales process? You don't have to navigate the complexities of this process alone. Instead, consider medical device consulting. Consulting with a professional company can help you find the advice and expertise you need. You can address compliance issues and streamline the process with help from an expert. Still on the fence? Here are six rewarding benefits of medical device consulting. By exploring these benefits, you can make a better choice for your business. Read on to learn more!

Behind every good medical device is a business plan. After the device has been developed, you need a plan for getting your product to market.

The FDA requires certain processes for new medical devices. FDA regulations can be time-consuming and expensive. But FDA approval is an essential step for any medical device.

The medical device industry depends on regulatory affairs professionals - but what do they do? Learn more about medical device regulatory affairs specialists. medical device regulatory affairs