The Applied Technical Services Family of Companies (FoC) offers medical device regulatory consulting services that help medical device manufacturers qualify their products for the marketplace.
Medical devices are an essential part of the lives of millions of people worldwide. Due to their importance and sensitive nature, these devices must undergo extensive testing that vets their quality, safety, and functionality. Our medical device testing experts work alongside our clients to ensure their products meet specifications while complying with industry standards and regulations.
About Our Medical Device Regulatory Consulting Services
Our medical device testing experts have decades of collective experience using mechanical testing to determine the strengths and weaknesses of medical devices. Our ISO / IEC 17025 accredited labs have the state-of-the-art equipment needed to simulate the real-world applications of medical devices, ensuring that the products can withstand the expected amount of wear and tear.
Our ability to conduct mechanical tests on medical devices makes us adept at consulting on matters about medical device designs and regulations. Upon completion of our testing, we share highly detailed reports of our findings with our clients and regulation agencies, maintaining an objective and transparent approach throughout the process.
We offer an extensive list of medical device regulatory consulting services, including the following:
- Audit regulatory consulting
- Clinical literature review
- Compliance support
- Distribution support
- FDA consulting
Why are Medical Device Regulations Important?
Medical device manufacturers must comply with an extensive list of regulations designed to protect patients, medical providers, and patients from the risks associated with poorly vetted medical devices. Failure to comply with rules will not only result in a device’s inability to be sold in the marketplace, but it can also lead to the following issues:
- Ineffective or even outright dangerous products
- Fines and legal penalties, including potential criminal charges
- Consumer dissatisfaction with products and distrust for a manufacturer
Contact Us
Please consider the ATS Family of Companies if your company needs a trustworthy medical device testing firm. Contact us today, by calling +1 (888) 287-5227 or completing an online service request.
