Borderless MedDev works on a variety of projects all with the goal of facilitating access to the US and world markets for medical instrumentation for our clients. While each project is unique, we are able to utilize our depth of experience to assure success working with the FDA and other agencies throughout the world as well as ISO registrars.
Unfortunately FDA clearance applications under section 510(k) of the Food, Drug, and Cosmetic Act do not always go as planned. Often the agency requests information that is not was not anticipated by the applicant. In these circumstances, companies not experienced with dealing with the FDA are often bewildered by the process and seek help.
Borderless MedDev has experience helping companies in this situation. We have worked with the FDA on numerous occasions to remediate the 510(k) applications and have been successful in achieving clearances for our clients.
FDA Submission Preparation and Filing
Our process starts by working with our clients to develop a regulatory strategic plan that fits their needs and helps them accomplish their goals. A solid plan considers not only how to legally market their medical product in the United States but also sets them up for competitive advantage.
Borderless MedDev leverages its extensive experience with FDA-recognized international standards and FDA guidances to full advantage to develop submission portfolios that are comprehensive and have the absolute best chance for clearance. In addition, we work directly with the agency from start to finish. This includes arranging pre-submission meetings or responding to FDA questions and feedback.
Quality Management System (QMS) Development
A robust quality management system is necessary to meet the requirements of the FDA Quality Systems Regulations, ISO 13485 and other applicable international standards. Borderless MedDev customizes quality systems to meet its clients' needs. This entails implementing elements of their QMS at the appropriate junctures to support their regulatory needs and overall company growth. In addition, our personnel can serve in fractional quality management roles within our clients' organizations allowing valuable resources to focus their efforts where most needed. Finally, we can provide the necessary training to assure our clients staff meets their requirements under FDA QSR, ISO 13485, ISO 9001 or ISO 15189.
Supplier Selection and Management
The Borderless MedDev team has extensive experience working with suppliers in the medical product space. We use this experience to assist our clients find and transition to new suppliers. This effort begins with analyzing and vetting potential suppliers paying particular attention to their ability to continue to perform at the necessary level of quality throughout the lifecycle of the product. We also get involved in the onboarding effort managing the transfer project to assure that the design will continue to perform to its specifications with the finished product and that all regulatory requirements are met. This effort often includes performing supplier audits and continued support.