Re: [PSES] MD clarification of the DoC

2018-12-19 Thread Pete Perkins
Dave,As with you, I have helped many companies write their MDoC or MDoInc; I typically get called in toward the end of a design project and am asked what needs to be done to get CE marking on the product, and am engaged almost right away with a project that is on a fast track. The MDoC is

Re: [PSES] MD clarification of the DoC

2018-12-19 Thread Nyffenegger, Dave
Ha, ha, I have written many DoCs and DoIs with the two names for my current company. Fortunately we already had resident employees in the EU that could be used to meet the technical file requirement. But before I started writing the DoCs it was clear whomever created the prior DoCs had not a

Re: [PSES] MD clarification of the DoC

2018-12-19 Thread Regan Arndt
Thanks Pete for that history lesson. My confusion lies on the fact that 2 different people and addresses can be on the MDoC. One for the DoC as a whole and one for the compiler. If I understand you correctly, it seems that it will be easier for the EU courts to fine/imprison someone in the EU