Quality Assurance & Regulatory Affairs
Telerescue is committed to pursuing quality for providing its customers with a package of quality dimensions fully meeting their requirements, ensuring that our products meet the most stringent quality standards, while continuously striving for improvement.
Telerescue has initiated a compliance with ISO 13485:2003 standard; toward obtaining CE mark for European distribution and FDA clearance for marketing in the US, aiming to demonstrate the quality of our medical device expertise.
During the year 2015, our Quality Assurance and Regulatory system is expected to be complied with and certified for standards and certifications, as well as fully meeting relevant international safety standards as follows:
510k FDA Clearance
IEC60601-1, IEC60601-2-22, IEC60825
EMC standards (EN60601-1-2, CFR 47 Part 2&15, ANSI C63.4)