QUALITY REMEDY provides life-science solutions in the form of Standard Operating Procedures (SOP’s), Records, Guides, and Webinar tutorials. Navigate the path from concept to market with our tiered Packages, below. Each Package focuses on a unique, yet necessary, aspect of medical product development that has been refined for quick implementation by innovative medical device companies.
The need to establish a Quality Management System [compliant to FDA (U.S. Food and Drug Administration) 21 CFR Part 820 and ISO (International Organization for Standardization) 13485] is a challenging task due the various subparts within the regulations. Our Quality Essentials Packages establish a set of robust processes that ensure your products are designed and manufactured to be safe, effective, and of the highest quality.
Turn to our Regulatory Packages to plan for a global regulatory strategy. Determine where to prioritize resources and how to register around the world - FDA 510(k) clearance & CE-Marking included. You will also learn how to incorporate ever-changing standards, guidelines, and regulations into product design. With our comprehensive process in place you can effectively develop new product iterations, remain lean, and scale your business.
Device design must be driven by procedures and measured by records. Browse all of our PACKAGES, below, and let us set you up for success. Demonstrate to investors that you have the foundation to generate sales. With a comprehensive process in place your company will remain lean, iterate products efficiently, and scale to new levels. Turn to QUALITY REMEDY and focus on your core competency - innovation.
Quality Management Systems are the backbone of any life-science organization. Laying the foundation for CAPA, Complaints, and Document Control processes ensures future success.click for more information
Define how you qualify, evaluate, monitor, and manage critical suppliers.click for more information
Navigate the global registration process with our guides that improve your 510(k), PMA, and CE-Mark submissions. Prioritize market entry by understanding the challenges and opportunities of global submissions.click for more information
Design Controls are critical to the development of any medical product - whether it is your initial product launch or next-generation product iteration.click for more information
Establish a Risk Management Process – a primary focus of device regulators and auditors.click for more information
Bootstrap the evolution of your medical device – fill in the gaps as you go.click for more information