CHINESE / 中文语言 
FRENCH / FRANCAIS 
KOREAN / 한국어 
GERMAN / DEUTSCH 
POLISH / JEZYK POLSKI 
JAPANESE / NIHONGO 
TURKISH / TÜRK DILI 
SPANISH / ESPAÑOL 
ITALIAN / ITALIANO 
There is Still Time for Some Validation Projects Prior to the MDR Deadline.
The revised deadline for MDR compliance is the, 26th of May 2021. There is still time to squeeze some device validation projects in for completion prior to this.
For your packaging sterile barrier stability testing, accelerated ageing usually delivers one year of real time ageing in 6.5 weeks. The last dates for the commencement of a 2 year shelf life verification are the 15th of February with ageing at 55°C, and the 15th of March with ageing at 65°C.
The final date for beating the deadline for ISO 11607 transit validation is the 26th of April. Projects using ASTM D4169 must commence before this date for compliance.
Surface contact medical devices need cytotoxicity, sensitization and irritation testing to meet the ISO 10993 biocompatibility rules. For MDR compliance, the latest start date for these studies is the 1st of March.
There is still time to get your work booked in. But be quick!
