MEDMONTS Co., Ltd is an end-to-end consulting service company for Medical Device Manufacturers. Established in June 2010, MEDMONTS is a nine-year-old consulting company easing certification for medical devices.
We, MEDMONTS, provide a one-stop consulting service for Medical Device Manufacturers from testing to certification covering CE, FDA 510(k), Health-Canada, J-PAL, NMPA, and MFDS(KFDA). In the case of MFDS (Korea), applicants (Manufacturers) need test reports issued by an MFDS authorized laboratory or otherwise will need to obtain CB certification, an area in which MEDMONTS is also specialized upon.
We are proficient in offering our testing service for Medical Device Manufacturer Clients. We prepare all necessary documents e.g. RM File including Usability and Software Lifecycle (62304). We have expertise in preparing all technical documents for CE/510(k)/J-PAL/MFDS/NMPA approvals. Right from testing (according to the latest standards e.g. IEC 60601-1 Ed. 3.1) to technical documentation, we are there with our clients all through the way until their medical devices get certified.
IEC 60601-1 Ed 3.1 Testing
IEC 60601-1 Ed 3.1 is a broadly recognized international standard, which ensures that the medical equipment tested is safe and effective to use. We are here to perform both hardware testing and software testing. We will also document the results of testing in order to comply with IEC 60601-1 Ed 3.1
Korean MFDS Approval
South Korea Medical Devices are regulated by the Ministry of Food and Drug Safety (MFDS), formerly called the Korean Food and Drug Administration (KFDA). If you are interested in marketing your products in Korea, then we can help you in acquiring Korean MFDS Approval for your medical device.
EU MDR 2017/745 Certification
A medical device with European Union Medical Device Regulation (EU MDR) 2017/745 Certification indicates that it is safe and efficient to use by Europeans. If you are waiting to perform the transition from MDD to MDR, then contact us immediately. We will do an in-depth gap analysis and revise all your documents accordingly.
Japanese PMDA Registration
If you are a medical device manufacturer interested in marketing your products in Japan, then you have to comply with the regulations of Pharmaceuticals and Medical Devices Act (PMDA). In order to sell or import or distribute your medical device in Japan, contact us to obtain PMDA Registration for your medical device.
China NMPA Registration
NMPA is the acronym of National Medical Products Administration. NMPA is responsible for governing and supervising the safety and quality of cosmetics, drugs and medical devices in China. If you are interested in marketing your products in China, then we can help you in completing NMPA Registration for your medical device.
Clinical Evaluation Report (CER)
A Clinical Evaluation Report (CER) is used to document the conclusion of your medical device's clinical evaluation. We are here to prepare CER according to MEDDEV 2.7.1 Rev 4 and we can evidently prove that the intended purpose of your medical device is met without subjecting the patients to any added risk.