Taiwan Yi Ding Medical Research Co. LTD
Writing of English technical document
We provide document writing guidance on European standard circuit diagram, exploded view, gas/hydraulic circuit diagram, user manual and various other information (in English).
Complete self-declaration or third party certification
Signing of declaration of conformity, completion of self declaration, entering the European market, or guidance on passing certification; third party certification by certification bodies such as TUV and DNV; obtaining CE certificate to improve a company’s image and increase competiveness.
Counseling products
Medical device directives (MDD): sunglasses, optical lenses, electronic thermometer, electronic musical pacifier thermometer, medicine feeder, stethoscope, neurological hammer, large sterilizer, ambu bag, ECG sub-regulation, surgical instruments (scissors, tweezers, knives), ophthalmic surgical microscope, intraocular lens, small sterilizer, surgical lights, glucose analyzer, optical lenses, uric acid analyzer, contact lens ...
Complete training course
CE introduction, Machinery Directive (MD), Medical Device Directive (MDD), In Vitro Diagnostic Directive (IVD), Risk Analysis (FMEA), Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC).
Product modification counseling
Based on the standards, we provide countermeasure guidance for improvement and assistance in testing voltage endurance, residual voltage, insulation, grounding, noise, wiring, voltage endurance, insulation testing and medical device. We also provide guidance on how to pass: sterilization, clinical trials, biocompatibility testing, cleanroom building and various specific standards.
Combining product’s CE specification with ISO
We provide guidance on how quality systems should be adjusted, to make the product’s CE specification comply with quality system ISO9001 / EN46001 / ISO13485 / cGMP.
Medical Equipment Counseling
Taiwan Yi Ding Medical Co. LTD
TEL 02-2269 0559 / 02-7722-0036
2F., No.2-1, Ln. 4, Chengtian Rd., Tucheng Dist., New Taipei City 236, Taiwan (R.O.C.)
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