The Applied Technical Services Family of Companies offers a wide range of specialized services to help clients achieve compliance with regulatory standards and requirements, setting us apart as a leader among FDA medical device compliance laboratories.
Medical Device Compliance Services
ATS’ FDA medical device compliance laboratory guides 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 compliance 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 compliance specialists 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 experts 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 compliance experts 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 specialists 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.
Applied Technical Services: a Leader Among Medical Device Compliance Laboratories
Maintaining compliance is vital to the medical device industry, and our specialists can help you ensure the quality of your supply chain, identify gaps in your quality management system, and guide you through European medical device regulations. ATS offers market readiness services for an impressive range of purposes, industries, and disciplines, ranging from predictive maintenance to FDA medical device compliance services. We provide a variety of market readiness services for the medical industry, including:
- ISO 13485 Gap Analysis
- FDA Supplier Audits
- FDA Vendor Audits
- European Medical Device Regulation Compliance
With nearly six decades of business experience, ATS is proud to be the preferred compliance 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.
