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Hi Yasser,  With all the good advice already provided by experts, I would suggest to look at IEC 62368-1 since it will replace IEC 60950-1 by December 20, 2020 in EU and if I am right then in US at the same time too.  So, if you are selecting a Class II power supply at this moment, it should be ...

Hi Ginger, Agreed. Thanks for correcting me, I took FDA as granted I guess being using MDSAP for 3 years. Yes, I don't think switch to ISO 13485 will be happening soon in current situation. Best Regards, ------------------------------ Saqib Tanweer Manager QA/RA Toronto ON Canada ...

Hi,  1- You need ISO 13485:2016 Certificate. 2- Decide which countries out of 5 you want to place your products in. You will have to comply with regulations of countries you selected. You can't distribute in a country that is part of MDSAP but for which you have not been audited. 3- All manufacturing ...

I agree with Richard, Salman and Victor on this issue. It has to be PRRC and has to be on job.  It's not like other business agreements.. If a CEO leaves a company it's a major change to your organizational structure, then if he was signing the DoC too so it's also affecting your products and processes. ...

Hi Peter, Since you mentioned thresholds, I am looking to have PSUR template ready for low-risk devices with no history of serious incidents and no thresholds defined before for identified risks. Is there a guideline to determine the suitable thresholds? With almost zero complaints, I am having ...