The need for the medical device industry to consider cybersecurity risks grows exponentially every year. In short, every company of any size risks ransomware attacks. However, it’s the products of medtech companies specifically that require more attention. The Need for Cybersecurity in MedTech Hospitals need medical devices to connect to hospital networks and the Internet […]
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Why Do You Need a Design History File? In short, the FDA requires a Design History File (DHF) as part of the application and marketing process for medical device manufacturers. First required by the United States FDA in 1990 as part of the Safe Medical Devices Act, the DHF contains all the product development documentation
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Congratulations on creating a marketable and perhaps life saving device. Now, it’s time to get your product safely and effectively to market. But first you’ll need FDA clearance or approval and that requires getting through the FDA application process. Let’s break it down step by step. Step 1. Understand the FDA First, understanding the role
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At first turning a concept into a marketable medical device feels daunting. Your great idea solves a critical concern in the health care field, however, the concept itself comprises the first step among many to getting your innovative product safely to market. The next critical steps turns that medical device into a physical product. So
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So you want to release your medical device or pharmaceutical product into the US or global market for your company expansion goals. Perhaps you are already behind on the timeline and over your budget. In order to get your product to market on time and within budget you need an expert. The Challenges of Getting
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Posted By: By Donna Mitchell-Magaldi, Nerac Analyst On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements Read More »
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