Medical Device Regulatory Experts specializing in FDA and CE compliance
F2 Labs is an FDA ASCA and A2LA ISO 17025 accredited laboratory who performs specialized certification, and compliance testing services tailored for the medical device industry. With a dedicated focus on ensuring the safety of medical devices, F2 Labs offers a range of services crucial for market acceptance. From electromagnetic compatibility (EMC) and radio frequency (RF) testing for the Federal Communications Commission (FCC) and Innovation, Science and Economic Development Canada (ISED Canada), to securing vital safety certifications like CE certification and U.S. (UL) and Canadian (CSA) certifications, F2 Labs is committed to providing exceptional service for our customers.
Electro-Medical Device Testing for FDA 510K approval and CE Certification
The company’s expertise extends beyond testing to encompass strategic regulatory compliance consulting, guiding clients through the intricacies of the ever-evolving regulatory landscape. Through its cutting-edge facilities and a commitment to client success, F2 Labs emerges as a trusted partner, empowering businesses in the medical device sector to navigate regulatory challenges and bring innovative and compliant products to market efficiently.
IEC 60601-1-2, AIM 7351731 and EMC Testing for RF Immunity
F2 Labs offers EMC testing services, including IEC 60601-1-2, AIM 7351731 and EMC Testing for RF Immunity, vital for medical device compliance in today’s market. Our test results are accepted by the FDA for use in your 510K submittal. The EMC testing we provide is critical for medical devices to ensure patient safety and uninterrupted healthcare operation. Trust F2 Labs for comprehensive testing services, regulatory compliance, and reliable device performance.
Wireless Coexistence Testing (IEEE/ANSI C63.27)
F2 Labs provides Wireless Coexistence Testing services to IEEE/ANSI C63.27 to ensure the reliable operation and safety of medical devices with wireless capabilities. This testing is crucial as wireless technologies, such as Wi-Fi and Bluetooth, are integral in healthcare settings. F2 Labs’ expertise in Wireless Coexistence Testing helps minimize interference risks, maintain patient safety, and ensure uninterrupted device performance in healthcare environments. Trust F2 Labs for comprehensive testing and compliance solutions in the field of wireless medical devices.
Product Safety Testing to IEC 60601-1, ANSI AAMI ES60601-1, and Other Particular Standards
We offer comprehensive Electrical Safety testing and evaluation services to ensure compliance with IEC 60601-1, ANSI AAMI ES60601-1 and CAN/CSA C22.2 No. 60601-1, which sets rigorous safety and performance criteria for medical electrical equipment. This standard mandates design and manufacturing to prioritize patient, operator, and user safety while defining essential performance criteria for intended functions. Risk management is emphasized across the device’s life cycle. IEC 60601-1 also covers electrical and mechanical safety, environmental conditions, and labeling, ensuring clear instructions for safe device usage. We can assist you in navigating the challenges that come along with complying with this standard and the other Particular Standards associated with it.
Essential Performance Consulting
F2 Labs offers consulting services to help you ascertain if your medical device has Essential Performance, and if so, we can guide you in the process of defining and identifying what the Essential Performance is. Essential Performance, per IEC 60601-1, refers to the critical functions that a medical device must fulfil to achieve its intended medical purpose and to ensure patient safety. These are the functions that, if compromised, could lead to unacceptable risks for patients, users, or others. Ensuring the essential performance is maintained under normal and fault conditions is a fundamental aspect of compliance with IEC 60601-1 and other related standards. We can provide you with the information you need to make the appropriate determinations.
F2 Labs can perform the evaluations required by IEC 60601-1-11 for Medical Devices/Systems used in a Home Healthcare environment. It focuses on the unique requirements and considerations for devices intended for use outside of traditional healthcare facilities. We can perform the evaluation to this Collateral Standard, and we can also perform the Shock and Vibration testing, as well as the Ingress Protection (IP) testing that it requires to ensure the product can still operate after exposure to water and/or dust. Contact us so we can determine what IP rating applies for your product.
F2 Labs was one of the first FDA ASCA accredited labs. The FDA Accreditation Scheme for Conformity Assessment (ASCA) program offers expedited market access for medical devices, reducing approval timelines and promoting innovation. This program enhances resource allocation, aligns with global standards, and upholds stringent quality standards, resulting in safer and more efficient medical devices for patients and increased regulatory efficiency for manufacturers. F2 Labs can provide you with an ASCA Summary Report to submit to the FDA for review.
Please click on the contact details above to find out how to get started on a proposal for testing today!