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.

Clinical Trial

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)

Obtain of the U.S. FDA 510k “approval” does not mean that a medical device can enter U.S. market. Most medical devices in the United States are covered by medical insurance companies, therefore, the medical device has to pass the hurdle of health insurer coverage in order for it to be available for an insurance patients’ use. Elliot MD provides professional services to assist Chinese device manufacturers to understand the U.S. health insurance policy, and to help the manufacturers to create reimbursement-dependent favorable conditions (including code, coverage policy and payment methodology) for selling the products in U.S..
In the next 5-10 years, biomedical industries will make major progress in the following areas: 1) medical robots, wearable medical equipment, mobile and remote medical equipment, radiotherapy equipment, medical diagnostic equipment, new biodegradable materials, new implants materials and tissue engineering-based medical devices; 2) cutting-edge research areas such as genomics, gene sequencing and gene editing, bio-electronics medical therapy, as well as advanced cellular and gene therapy; 3) areas of medical equipment + medical services, such as medical equipment + Internet, data processing center + independent software, clinical samples + personalized medical products, and shared health care.

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:

Bone screws

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

Biocompatibility

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.