Hazardous Materials
3:45 PM - 5:00 PMWed
Speakers
Emma Brennen
Medical Device Compliance - Engineering
Claigan
Nic Pugliano
Regulatory Affairs Associate
W. L. Gore
Nathan Da Silva
EU MDR Subject Matter Expert
Edwards Life Sciences
* . Getting the needed information? From suppliers? Testing? * . Strategy for testing (how ensure all chemicals tested? Ot risk based approach? how make sure the latter is robust? * . Finding a suitable test house? * . Managing the data * . Doing the calculations? At the article level? What is an article? (every part?) Is the BoM sufficiently detailed? If not, what can I do?