U.S. Elliot Medical Solutions Provides Professional Services to Help Your Biomedical Devices and Products to Enter U.S. Market
The U.S. FDA has established classification for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Classification is risk based, that is, the risk the devices poses to the patient and/or to the user is a major factor in the class it is assigned. Each types of devices are assigned to one of the three regulatory classes (Class I, II and III) based on the level of control necessary to assure the safety and effectiveness of the device. For devices classified as Class I or II (if it is not exempt), a 510k will be required for marketing. For devices classified as class III, a premarket approval application (PMA) will be required unless your device is a pre-amendments device.
Based on the device classification, time and cost, it is necessary for Chinese manufacturers to build a strategy to obtain FDA’s “approval” of medical devices to meet your marketing plan. We provide professional services for you to pass the regulatory hurdles of U.S. FDA.
Our goal is to help Chinese Biomedical industries to bring your devices and products to U.S. market. We provide:
U.S. FDA Regulatory Submissions
--- U.S. FDA 510(k), 513(g), Pre-IDEs, PMA and IDEs
--- U.S. FDA Establishment Registration and Product Listing
--- Import/Export requirements, FDA Certificate to Foreign Government (CFG)
--- Official Correspondent and US Agent. Representative of Chinese industry to fully communicate with FDA.
Help you to manage your clinical trials
Quality Systems Development
Help you to establish quality system which is required to ensure the methods used in, and the facilities and controls used for the design, manufacture, packaging, labeling, and storage of all devices are compliant with current regulations. A quality system must be I place before brining your device to market.
--- Quality System Requirements (21 CFR 820)
--- Unique Device identification (UDI)
--- International standard for quality management systems (ISO 13485)
For these emerging areas, the U.S. Elliot MD provides a multidisciplinary team of experts to build strategic, reliable and feasible medical solutions for Chinese manufacturers and developers to integrate resources, incubate and create new generation of competitive medical devices. This will enable Chinese device manufacturer to gain more opportunities and take the lead in the fast-developing field of medical device.
Area of Expertise
--- Orthopedic Implants
We help you to perform characterization, identify problems and solutions
We provide analysis of over 700 components of retrieved orthopedic implants. Results of the analysis support U.S. FDA regulatory submissions of innovative biomedical devices, also support the development of drug delivery systems and antimicrobial coating technology for implants and other medical applications. Specific areas of expertise include:
Joint replacement implants
Surface & coating technology
Urology and lithotripsy technology biomedical device
In vitro diagnostic devices
Dental implants and restoration materials
Material and component characterization
Disinfection, sterility, cleaning validation
Bioceramic, calcium phosphate, absorbable polymers
--- Biological Assays
We provide Contract Research Lab for biological assays。
We provide biological assays for your project. We provide specialized custom and high throughput assays using mammalian and human cells as well as microbiological assays. We are also skilled in cytotoxicity, cell proliferation, adhesion and viability, drug delivery and establishment of dose-responses.
--- Drug Delivery
Transdermal & Fentanyl patches
We provide experts and consultants who are experienced in methods and analysis for drug delivery including transdermal patches, drug eluting coatings and biomaterials and antimicrobial technologies. We also provide consultants who have expertise with the drug hydromorphone, oxycodone, fentanyl, codeine, and hydrocodone, MS Contin, Oxycotin and Ryzolt.