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FDA process

QUICK GUIDE: MEDICAL DEVICE REGULATIONS & DEVELOPMENT

Medical device regulations are not the easiest material to understand. If they were, then every Fortune 500 company would build a smart wearable....

How to Avoid Cyber threats

7 KEYS TO AVOID MEDICAL DEVICE CYBERSECURITY THREATS

Fact is stranger than fiction, indeed. Sometimes is it scarier. In terms of medical products, the latter is increasingly becoming more frequent....

QUALITY REMEDY is dedicated to helping companies understand and comply with medical products regulations. We help identify your most pressing business needs – from development to post-market surveillance. See the fastest path to market and avoid pitfalls. From 510(k) support to starting a Quality System, your solutions are here under one roof. Define the variables. Execute the plan.

The need to establish a Quality System to FDA and ISO 13485 is difficult. Most firms get into trouble by not prioritizing it. Our QUALITY packages will help you setup the processes to make safe and effective devices. Turn to our REGULATORY packages to plan for a global launch strategy. Know how and where to register around the world – from FDA 510(k) clearance to CE-Mark approval. Learn how to incorporate evolving standards, guidelines, and regulations into product design. Develop new product iterations, remain lean, and scale your business. Show investors that your product will change the world. With a proper process in place your company can focus on its core competency – innovation.