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NIS2 and the Challenge of Turning Risk into Opportunity

You wouldn’t believe how many times, when trying to conduct a Risk Analysis in an organization, we’ve heard things like: “If we only think about the bad stuff, we’ll never get anything done,” “There’s no time to assess risks, we need to sell,”or the classic “We focus on goals, not risks… if something happens, we’ll … Continuado Leer más...

Is your CCRA aligned with the realities of your plant?

It has now been 10 years since the last revision of Chapters 3 and 5 of the GMP Guidelines came into force. One of the main objectives of that update was to align its content with the “Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products … Continuado Leer más...

Everything You Need to Know About the 510(k) Process

Navigating FDA requirements can be complex, and the 510(k) process is no exception. If you’re developing a medical device for the U.S. market, understanding this process is essential. In this article, we answer the most common questions about who needs to submit it, when it’s required, and what exemptions apply. What is a 510(k)? A … Continuado Leer más...

Qloud Qualificates: The New Digital Qualification Service

The pharmaceutical industry is constantly evolving, and digitizing critical processes such as equipment qualification is key to improving efficiency, safety, and regulatory compliance. To transform the qualification process, we are launching Qloud Qualificates, a system designed to digitize qualification, optimize time, minimize errors, and ensure secure and efficient document management. 1. Time Savings and Greater … Continuado Leer más...

FDA Medical Device Registration: Pathways to Market Approval

Navigating the FDA registration process can be complex, but choosing the right pathway is key to bringing your medical device to market successfully. 1. Self-registration  FDA Class I and Class II Device Exemptions Most Class I devices and some Class II devices are exempt from premarket notification requirements. However, this does not mean they are … Continuado Leer más...

Medical Device Registration with the FDA: Key steps and requirements

The registration of medical products with the United States Food and Drug Administration (FDA) is a crucial step for companies seeking to market their products in one of the largest and most regulated medical device markets in the world. However, the process can be complex, especially for those unfamiliar with industry regulations. For this reason, … Continuado Leer más...