MEDMONTS Consulting

Our CEO Dr.Woo Sung Park, is the man behind the success of Medmonts Co., Ltd. He started studying medical devices at TUV-SUD as a Medical Device Certification Team Lead (NB auditor) during the period 1997~2010 and that understanding made him the founder of MEDMONTS.

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Not just him, we have an excellent crew of regulatory experts specialised as below, who will guide you with their best ideas.

• IEC 60601-1 Consultant

• QMS Consultant

• RA Consultant

• Software Consultant

• Clinical Affairs Expert

MEDMONTS Co., Ltd is an end-to-end consulting service company for MEE/MES Manufacturers. MEDMONTS is a nine-year-old consulting company easing certification for medical devices.

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We, MEDMONTS, provide 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 case of MFDS (Korea), applicants (Manufacturers) need test reports issued by an MFDS authorised laboratory or otherwise will need to obtain CB certification, an area in which MEDMONTS is also specialised upon.

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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.