Our Blog

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.

We are delighted to announce the launch of our new website!

Are you wondering how you can choose between the top consulting companies for medical devices? Read on and learn more here. Medical device companies don't often have al

The FDA medical device approval process has changed several times over the years. We take a look at how these processes work now. In 2020, there were 40 medical devices passed by the

From the global semiconductor shortage to the uptake of artificial intelligence, we look at the medical device industry trends to watch. In the last few decades, everybody has experienced rapid advancements and revolutions in

The deadline for EU MDR Audit Readiness has come and gone. Now, medical equipment manufacturers are operating in a new, amplified regulatory environment. The EU MDR

Are you in the market for a medical devices consultant? Read here for nine practical tips for choosing the right medical devices consultant for your needs. Any scientific professional knows

Are you swamped with medical writing projects? Click here for nine amazing reasons that you should start outsourcing your medical writing projects. Are you finding all your effort

Are you interested in learning more about the role of a medical devices consultant? Read more about medical devices consulting here. You've got an amazing medical device ready to

Do you manufacture or use medical devices sold in the European Union (EU) market? If so, are you in compliance with the EU Medical Devices Regulation (EU MDR)? The COVID-19

What are the current regulatory standards for medical equipment? This is a guide to the latest medical regulations and the transition to EUMDR. The European Union has the second-largest medical device market after the US. Yo

Are you looking to hire a regulatory consulting company for your medical practice? Find out what you need to know by clicking here. Getting your new medical device to the market

Entering into the medical industry and not sure what devices you should invest in? Here's a list of the top 8 medical devices you should consider.

Have you been directed to a medical device consultant? Discover all you need to know about medical device consultants and make sure you get the best care today! There were 1,044,706 active physicians in the U.S. in

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

Are you considering hiring a medical device consulting service? Discover all you need to know and how to choose the best services for your company. Consulting services