memo_artifacts_standards_cfr_21_820

SysML API

Public namespace	memo::artifacts::standards
Declared package	memo_artifacts_standards_cfr_21_820
Source	src/artifacts/standards/cfr_21_820.sysml

Namespace hierarchy

memo → memo::artifacts → memo::artifacts::standards

Packages

Package
memo_artifacts_standards_cfr_21_820

Imports

Visibility	Target
private	ScalarValues::*
private	memo_core_enumerations::*
private	memo_core_relationships::*
private	memo_artifacts_standards_traceability::*

Declarations

Name	SysML kind	Description	Specializes
—	—	—	—

Source

artifacts/standards/cfr_21_820.sysml

// 21 CFR Part 820 — FDA Quality System Regulation, design controls.
//
// Only §820.30 (design controls) and its paragraphs are represented: those are
// the provisions a design history file traces to. The production, purchasing
// and records subparts are QMS scope that no model element claims.
//
// Terminology: under QMSR (effective February 2026) Part 820 incorporates
// ISO 13485:2016 by reference, so a project may end up claiming both this pack
// and the 13485 one for the same document. That is two claims about one
// artifact, which is exactly what ConformsTo is for — it is not a duplicate
// registry.
package memo_artifacts_standards_cfr_21_820 {
    private import ScalarValues::*;
    private import memo_core_enumerations::*;
    private import memo_core_relationships::*;
    private import memo_artifacts_standards_traceability::*;

    item cfr21Part820 : RegulatoryStandard {
        attribute :>> id = "STD-21-CFR-820";
        attribute :>> name = "CFR21Part820";
        attribute :>> designation = "21 CFR Part 820";
        attribute :>> issuer = "FDA";
        attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
    }

    item cfr820_30 : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30";
        attribute :>> name = "CFR820_30";
        attribute :>> clauseNumber = "820.30";
        attribute :>> title = "design controls";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30a : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-A";
        attribute :>> name = "CFR820_30a";
        attribute :>> clauseNumber = "820.30(a)";
        attribute :>> title = "general design control applicability";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30b : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-B";
        attribute :>> name = "CFR820_30b";
        attribute :>> clauseNumber = "820.30(b)";
        attribute :>> title = "design and development planning";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30c : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-C";
        attribute :>> name = "CFR820_30c";
        attribute :>> clauseNumber = "820.30(c)";
        attribute :>> title = "design input";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30d : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-D";
        attribute :>> name = "CFR820_30d";
        attribute :>> clauseNumber = "820.30(d)";
        attribute :>> title = "design output";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30e : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-E";
        attribute :>> name = "CFR820_30e";
        attribute :>> clauseNumber = "820.30(e)";
        attribute :>> title = "design review";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30f : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-F";
        attribute :>> name = "CFR820_30f";
        attribute :>> clauseNumber = "820.30(f)";
        attribute :>> title = "design verification";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30g : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-G";
        attribute :>> name = "CFR820_30g";
        attribute :>> clauseNumber = "820.30(g)";
        attribute :>> title = "design validation";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30h : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-H";
        attribute :>> name = "CFR820_30h";
        attribute :>> clauseNumber = "820.30(h)";
        attribute :>> title = "design transfer";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30i : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-I";
        attribute :>> name = "CFR820_30i";
        attribute :>> clauseNumber = "820.30(i)";
        attribute :>> title = "design changes";
        attribute :>> normativeStrength = "shall";
    }
    item cfr820_30j : StandardClause {
        attribute :>> id = "STD-21-CFR-820-30-J";
        attribute :>> name = "CFR820_30j";
        attribute :>> clauseNumber = "820.30(j)";
        attribute :>> title = "design history file";
        attribute :>> normativeStrength = "shall";
    }

    connection cfr820Has30 : Composes connect parent ::> cfr21Part820 to child ::> cfr820_30;

    connection cfr820_30HasA : Composes connect parent ::> cfr820_30 to child ::> cfr820_30a;
    connection cfr820_30HasB : Composes connect parent ::> cfr820_30 to child ::> cfr820_30b;
    connection cfr820_30HasC : Composes connect parent ::> cfr820_30 to child ::> cfr820_30c;
    connection cfr820_30HasD : Composes connect parent ::> cfr820_30 to child ::> cfr820_30d;
    connection cfr820_30HasE : Composes connect parent ::> cfr820_30 to child ::> cfr820_30e;
    connection cfr820_30HasF : Composes connect parent ::> cfr820_30 to child ::> cfr820_30f;
    connection cfr820_30HasG : Composes connect parent ::> cfr820_30 to child ::> cfr820_30g;
    connection cfr820_30HasH : Composes connect parent ::> cfr820_30 to child ::> cfr820_30h;
    connection cfr820_30HasI : Composes connect parent ::> cfr820_30 to child ::> cfr820_30i;
    connection cfr820_30HasJ : Composes connect parent ::> cfr820_30 to child ::> cfr820_30j;
}