Our Experience

Drug		PMF applifaction in compalince with PIC/S GMP/Generic Drug filing
		DMF/API application
Quality System		ISO 13485/TFDA QMS/MDR QMS
		MDSAP _US_Brazil
		GDP
MDR 2017/745	Technical Documentation/CER	Acupuncture Needle
		Face Mask
		Nebulizer
		Anti-Decubitus Air Mattress
Medical Device
	Ophthalmic Devices:	Contact Lens FDA 510K/TFDA registration,
		Contact Lens clinical study
		Direct Ophthalmoscope/Indirect Ophthalmoscope
		Ophthalmic Endoscope
	Cardiovascular Device：	Drug Eluting Stent
		PTCA / CTO
		Diagnostic Catheter / Guiding Catheter
		Blood Pressure Monitor system, central aortic systolic pressure monitor
	Dental Devices：	Porcelain powder for clinical use
		dental implant system including abutment..
	Anesthesiology Devices：	CPAP/Humidifier
	Immunology and Microbiology devices：	Gastrointestinal pathogen, Respiratory Virus panel PCR kits, fecal calprotectin ELISA, Rapid Test_ SARS-CoV-2(COVID-19) Neutralizing Ab Test …
	General and Plastic Surgery Devices：	Ultrasound, Laser, RF, Picocare Laser instrument….
	Obstetrics and gynecology Devices：	Abortion Cannula, Trocar…
	Orthopedic Devices：	Pedicle screw, cage, spinal fixation…
	Physical medicine Devices	power muscle stimulator
	Neurology Devices	EEG, EMG, ECG, High Intensity focuse ultrasound for essential tremor (HIFU)
	Gastroenterology and Urology Devices
	General Hospital and Personal Use Devices	Face Mask, Glucosemeter, Sterilizing container system
	Radiology Devices
	Clinical Chemistry and Clinical Toxicology Devices
	Hematology and Pathology Devices	ADAMTS-13 activity ELISA KIT
	Ear, Nose, and Throat Devices

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Jens Medical Consulting Ltd.

TEL：886-2-82823192｜FAX：886-2-82867686｜E-Mail：jen.medical@msa.hinet.net
3F. No 364, Jixian RD, Luzhou Dist. New Taipei City, Taiwan ROC