Thank you for a very helpfull piece of advise, when you suggested that I should write a rationale for me being appointed as PRRC in my company. Only a few days later, the auditor asked for it during our Tech File Assessment before (hopefully) achieving our MDR CE certificate.
The strategic consequences of specific Basic UDI-DI groupings As can be read elsewhere, a Basic UDI-DI groups devices with the same intended purpose and the same essential design and manufacturing characteristics into device families. Within this context a company can chose to apply various levels of granularity. This freedom should be used with great caution, … Read more
Boumans Regulatory Consulting BV
