The Applied Technical Services Family of Companies (FoC) offers FDA medical device consulting services. Medical devices have improved the lives of millions of people worldwide and their continuous advancements will ensure that the number steadily rises. The FDA regulates these medical devices, ensuring that they’re effective and safe for their end users, and our medical device experts help businesses comply with and prepare for these regulations.
Why Does the FDA Establish Medical Device Regulations?
The FDA regulations the sale of medical devices in the US ensuring that these devices are well-intended and safe to use. The FDA requires that manufacturers comply with their regulatory requirements before the device enters the market. The FDA divides medical devices into three categories, Class 1, 2, and 3 devices. The regulations strengthen as the class increases due to the increased sensitivity of the device’s purpose. For example, an elastic bandage is a Class 1 medical device whereas a pacemaker is a Class 3 device. If not properly designed or used, the pacemaker poses significantly more risk than a bandage, requiring more testing and scrutiny.
Our FDA Medical Device Consulting Services
Our medical device testing experts consult with clients, helping them navigate the ever-evolving landscape of medical device regulations. Our staff is trained according to the standards of the Regulatory Affairs Professionals Society (RAPS), many of which have also earned their Regulatory Affairs Certification (RAC). In addition to our FDA quality and regulatory consulting services, we offer the following:
- Regulatory support, including compilation, deficiency support, and review
- Distribution and shipping validation
- Compliance support
- Quality system improvement and development
- Educational courses and programs
- Sterilization and cleaning verification
Why is FDA Compliance Important for Medical Device Manufacturers?
The FDA enforces regulations to ensure medical device manufacturers develop safe and effective products that pose minimal user risk. Noncompliance with FDA standards can present a series of serious issues for manufacturers, including:
- Fines
- Legal actions
- Consumer dissatisfaction due to poor product performance or quality
Contact Us
Please submit an online request or call +1 (888) 287-5227 to speak with an ATS representative about our FDA medical device consulting services.
