Type testing, CB/UL/Informative Report, Brazil INMETRO

• IEC 60601-1 series / GB 9706.1 series safety and EMC testing

• PI (Preliminary Investigation) product structure pre-review, component selection, Critical component list/insulation diagram review, waterproof and fireproof requirements, accompanying documents review, etc.

• IEC 60601-1-6/ IEC 62366-1 usability document review

• ISO 14971 RM documentation review

Reusable medical device reprocessing

• Material analysis and compatibility testing

• Reprocessing program design

• Reprocessing effectiveness Verification