The Applied Technical Services Family of Companies offers a wide range of consulting services to help clients achieve compliance with regulatory standards and requirements, including FDA medical device consultant services.
Medical Device Consultant Services
ATS’ FDA medical device consulting services guide clients through the extensive and complex process of attaining compliance with standards and regulatory requirements set by the Food and Drug Administration. Bringing a medical device to market involves a detailed and complicated process that requires a deep understanding of regulatory requirements, scientific principles, and clinical data.
Our diverse consulting services assist clients through every stage of the product life cycle, from concept development to post-market data analysis. ATS helps clients ensure that medical devices meet FDA standards for safety and performance, ultimately streamlining the process and avoiding potential delays or rejections.
Strategy Development
Applied Technical Services’ medical device consultants specialize in regulatory strategy development. Before manufacturers can submit a device for approval, they must determine which regulatory pathway is most appropriate. This could involve the Premarket Notification process, Premarket Approval, or the De Novo classification, depending on the risk level and intended purpose of the device.
Our consultants help manufacturers understand these options and decide the best strategy based on the specific product. This early-stage guidance is invaluable, helping clients avoid common pitfalls that could result in costly delays or even failed submissions.
Documentation, Audits, and Support
ATS’ FDA medical device consultants provide support in preparing the required documentation for submission to the FDA, including clinical and non-clinical data compilation, creating detailed technical files, and ensuring that all tests and evaluations are conducted in accordance with FDA guidelines.
Our consultants also conduct audits, help implement quality management systems, and advise on staff training. After achieving compliance, we offer post-market analysis to monitor device performance and report any adverse events to the FDA.
The Medical Device Consultants at Applied Technical Services
ATS offers consulting services for an impressive range of purposes, industries, and disciplines, ranging from predictive maintenance consulting to FDA medical device consultant services. With nearly six decades of business experience, ATS is proud to be the preferred consulting services provider for some of the nation’s most esteemed companies, organizations, and businesses.
Give us a call today to request additional information, get a free quote, or schedule a service. A member of our customer service team will be happy to assist you at 1 (888) 287-5227.
