The ATS Family of Companies offers regulatory consultant services for medical devices, helping to guide manufacturers through the complexities of achieving and maintaining compliance with regulations and safety standards.
Regulatory Consultant Services for Medical Device Manufacturers
As medical devices can be responsible for patient comfort, mobility, and organ functionality, making their safety and reliability extremely important. ATS’ medical device compliance consultants help clients navigate the various standards and regulations that govern the development, manufacturing, marketing, and distribution of medical devices. Our consultants are experts in understanding the strict and specific rules set by regulatory bodies like the U.S. Food and Drug Administration, the European Medicines Agency, and other international health organizations. Consultant expertise helps to ensure that medical devices meet all safety and quality standards before they are introduced to the market.
Our regulatory consultants provide hands-on assistance to guide medical device manufacturers through the regulatory approval process, starting with compiling and submitting technical documentation containing detailed information about the device, its design, the manufacturing process, risk assessments, clinical data, and quality control protocols. ATS’ experienced consultants ensure that every aspect of the product meets the necessary regulatory guidelines, which vary depending on the classification and intended use of the device.
Maintaining Compliance for Medical Devices
One of the most significant challenges in the medical device industry is adhering to constantly evolving regulations. In the United States, medical devices are classified as Class I, II, or III, with more extensive requirements based on the device’s purpose and its potential risk to patients. The regulatory consultants at ATS determine the correct classification of client devices and the appropriate strategy to achieving market approval, whether through the FDA’s 510k premarket notification process, premarket approval, or another regulatory route.
In addition to guiding the regulatory submission process, our consultants can help clients maintain compliance throughout the product’s lifecycle. This includes advising on post-market monitoring for the safety and performance of devices once they are in use. ATS’ experts assist in setting up systems for reporting incidents, conducting periodic safety updates, and ensuring ongoing compliance with regulatory standards.
The Medical Device Consulting Experts at Applied Technical Services
At Applied Technical Services, we pride ourselves in offering a wide range of comprehensive services for various industries and disciplines, offering clients a one-stop shop for all their testing, analysis, inspection, certification, and compliance needs.
Call us today at 1 (888) 287-5227 for additional information or a free quote on regulatory consultant services for medical devices, or submit a request form on this page.
