Article 15 requires manufacturers to have permanently available within their organisation at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise in the field of in vitro diagnostic medical devices. The PRRC has the formal responsibility to ensure: (a) the conformity of devices before release; (b) technical documentation and the EU DoC are drawn up and kept up to date; (c) post-market surveillance obligations (Article 10(9)); (d) vigilance reporting (Articles 82-86); (e) for investigational devices, the Article 70 declaration. Article 15(2) permits micro-enterprises / small enterprises to engage an external PRRC.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.