Article 15 requires manufacturers to have permanently available at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise. The PRRC has formal responsibility to ensure: (a) device conformity before release; (b) technical documentation + EU DoC are drawn up and kept up to date; (c) PMS obligations; (d) vigilance reporting (Articles 87-92); (e) for investigational devices, Article 62 declaration. Article 15(2) permits micro/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.