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Hi Nataliya, I strongly recommend Welocalize Life Sciences . They provide quality service within the agreed SLA. They even provide translation certificates for each project.  We are happy with their services offered till date. Regards, Soumya ------------------------------ Soumya Rajesh ...

Dear RAPS Members, Do we have to test the requirements of clause 15.3 of IEC60601-1 if the collateral standard applicable for our device states compliance to 15.3  is not applicable? The collateral standard also states that it takes precedence over the corresponding requirements of IEC 60601-1 if ...

Hi Thi Nguyen, Sorry! I somehow didn't notice your question. Yes! This was part of the audit and indeed accepted by the auditor. Yes! We do use JIRA for software bug tracking as well and the same approach was followed for validation. Regards, Soumya ------------------------------ Soumya Rajesh ...

Dear Al van Houdt Thanks for your valuable feedback! Regards, ------------------------------ Soumya Rajesh Quality and Regulatory Affairs Manager Den Haag Netherlands ------------------------------

Dear Ed Panek, The change is not a result of any CAPA. It was initiated to avoid mishandling by forwarders. More of business risk mitigation than product safety. Regards ------------------------------ Soumya Rajesh Quality and Regulatory Affairs Manager Den Haag Netherlands ----------- ...