Quality Management | Regulatory Submissions | Product Development

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.

pulse oximeter fda 510kglucose meter fda 510kvital signs monitor fda 510kmetal hip implant replacement fda 510k
pacemaker fda 510kinfusion pump fda 510kwearable fda 510kMRI fda 510kDICOM fda 510kdiagnostic imaging fda 510kendoscope video processor fda 510k


  • * tailored for products of various intended uses & indications
  • * customizable for quick implementation
  • * trainings and webinars for designers & manufacturers


Bootstrap the evolution of your medical device – fill in the gaps as you go.

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Device companies in the U.S. must comply with 21 CFR Part 820, while those in the rest of the world generally comply with ISO 13485. Our Full Product Offering complies with both, and brings clarity to establishing a quality system.