Welcome to Quality Professionals Inc., your trusted partner in medical device market entry and compliance. With years of experience in the medical device industry, we specialize in guiding you through the complexities of EU MDR compliance and FDA 510(k) submission, ensuring your products meet global regulatory standards. Our expert team provides comprehensive services, including medical device risk assessment, ISO certification for medical devices, and ISO 13485 implementation, to help you maintain quality and compliance throughout your product lifecycle.
We offer in-depth medical device gap analysis to identify regulatory and quality management system gaps, and provide customized solutions to ensure seamless market entry and regulatory approval. Whether you’re launching a new product or expanding into new markets, we are here to support your success by aligning regulatory strategies with business goals. Let us help you navigate the regulatory landscape efficiently and bring safe, innovative medical devices to market.
Label & IFU Review Services:
The manufacturer is required to provide the user or patient with appropriate information such that the product can be used both safely and effectively throughout its lifetime.
Labelling mistakes can be very costly and we understand that all these requirements can sometimes be difficult to keep up with. Let us have a look at your labels or instructions for use and we will let you know what’s missing and where you can improve.
You may also contract us to develop a regulatory plan for meeting your labelling and IFU requirements. We will provide you with a document detailing exactly what information should be placed on your device / packaging / IFU and which international symbols should be indicated.