Título de la publicación de blog cuatro

Escrito por Pierre-Antoine Deglesne

Todo empieza con una idea. Tal vez quieras comenzar un negocio o convertir un pasatiempo en algo más. O bien, es posible que tengas un proyecto creativo para compartir con el mundo. Sea lo que sea, la manera en la que cuentes tu historia online puede marcar la diferencia.

No te preocupes por sonar profesional. Suena como tú. Hay más de 1500 millones de sitios web, pero tu historia es lo que lo diferencia del resto. Si vuelves a leer las palabras y no oyes tu propia voz en la mente, es una señal de que aún tienes mucho trabajo por hacer.

Sé claro, ten confianza y no lo pienses demasiado. La belleza de tu historia es que continuará evolucionando y tu sitio evolucionará con ella. Tu meta debe ser que sea correcto para el momento. Más tarde, funcionará solo. Siempre es así.

Change Control Process - Simplified Swimlane

Change Control Process - Simplified Swimlane Diagram

Standard Operating Procedure: Change Control & Design Change Control

Per ISO 13485:2016, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820.30

Simplified view showing essential requirements only

STAGE
KEY ACTIONS
RESPONSIBLE
6.1

CHANGE INITIATION

ISO 13485:2016, §8.5.1, §8.5.2

6.1
DELIVERABLE:
F-414-001 Section A completed
TIMING:
5 business days

Change Request Documentation

Identify change need from any source (CAPA, PMS, audit, complaint)
Assign unique Change Request ID (CR-ID-XXXXX)
Document detailed description and rationale
Submit to Quality Manager via eQMS
Change Requester
6.2

IMPACT ASSESSMENT

ISO 13485:2016, §7.3.9, §4.1.4

6.2
DELIVERABLE:
F-414-001 Section B completed
TIMING:
10 business days

Areas Affected by Change

Identify affected areas: QMS, Design, Manufacturing
List affected processes per ISO 13485:2016
Document all affected documentation (§4.2.4)
Assess stakeholder impact (internal & external)
Quality Manager + PRRC
6.3

REGULATORY IMPACT

EU MDR 2017/745, Art. 120 | EU IVDR 2017/746 | MDCG 2020-3 Rev.1

6.3
DELIVERABLE:
F-414-001 Section C completed
TIMING:
Per regulatory timelines

Change Classification & Notification

Classify change: Substantial or Minor per MDCG 2020-3 Rev.1
Apply MDCG assessment methodology (Main Chart + Sub-charts A-E)
Determine Notified Body notification requirements
Assess Competent Authority & EUDAMED updates needed
PRRC / Técnico Responsable
6.4

RISK ASSESSMENT

ISO 14971:2019 | EU MDR/IVDR Annex I

6.4
DELIVERABLE:
Risk analysis completed - Section B(4)
TIMING:
Per SOP-710

Risk Management Activities

Perform risk analysis per ISO 14971:2019, §5 (FMEA/Risk Matrix)
Identify new hazards & assess impact on existing hazards
Review risk control measures (§6)
Update Risk Management File (§7)
Quality Manager + Risk Manager
6.5

CHANGE APPROVAL

ISO 13485:2016, §7.3.9, §5.4.1

6.5
DELIVERABLE:
F-414-001 Section F signed
TIMING:
15 business days

Management Review & Decision

Review impact & risk assessment completeness
Evaluate regulatory implications & NB requirements
Confirm resource availability & timeline feasibility
Make decision: Approve or Reject (document rationale)
Quality Manager + Management Rep
6.6

CHANGE PLANNING (If Design Change)

ISO 13485:2016, §7.3, §7.3.2 | FDA 21 CFR 820.30

6.6
DELIVERABLE:
F-739 Sections 1-2 completed (if required)
TIMING:
Before execution

Design Change Management

Establish Design Change Team (mandatory: CM, Dev, QA, Independent Reviewer per §7.3.2)
Identify impacted design control elements (14 elements)
Plan Verification activities (§7.3.5) & Validation activities (§7.3.6)
Define timeline, milestones, and resource requirements
Change Manager + Design Change Team
6.7

CHANGE REALIZATION

ISO 13485:2016, §7.3.5, §7.3.6, §7.3.2

6.7
DELIVERABLE:
V&V complete, DHF/TF updated, Design Review done
TIMING:
Per project plan

Execute, Verify, Validate & Review

Execute design changes (update inputs/outputs, specifications, software)
Perform Verification per §7.3.5 (design outputs meet inputs)
Perform Validation per §7.3.6 (product meets user needs)
Update DHF, Risk File, Technical File, Traceability Matrix
Conduct Design Review per §7.3.2 with Independent Reviewer (F-730-049)
Design Change Team + Independent Reviewer
6.8

REGULATORY APPROVAL (If Substantial Change)

EU MDR 2017/745, Art. 120, Annex IX, §4.10 | EU IVDR 2017/746

6.8
DELIVERABLE:
NB approval & CA notification complete
TIMING:
30-90 days (NB review)

Notified Body Submission & Approval

Prepare NB notification package (V&V results, risk assessment, updated TF)
Submit to Notified Body per Annex IX, §4.10
Obtain NB approval & updated EC Certificate
Notify Competent Authority & update EUDAMED (Art. 29/26)
PRRC / Técnico Responsable
6.9

CHANGE IMPLEMENTATION (RELEASE)

ISO 13485:2016, §4.2.4, §6.2, §7.5, §7.5.9

6.9
DELIVERABLE:
v2 released to production/market - Section H complete
TIMING:
Per implementation plan

Release & Stakeholder Notification

Release documents per §4.2.4 (withdraw obsolete versions)
Execute production changeover (§7.5) & validate if required (§7.5.6)
Conduct training per §6.2 (document competence verification)
Release v2 to market per §7.5.9 (product release control)
Notify stakeholders: suppliers (§7.4), customers (§7.2.3), distributors
Quality Manager + Operations + Change Manager
6.10

VERIFICATION & CLOSURE

ISO 13485:2016, §4.2.5, §8.2.4 | FDA 21 CFR 820.30(j)

6.10
DELIVERABLE:
F-414-001 Section J signed, all records archived
TIMING:
Post-implementation

Effectiveness & Final Closure

Verify all implementation activities complete (Section I)
Evaluate change effectiveness per §8.2.4 (original issue resolved, no negative impacts)
Review PMS data if applicable (EU MDR Art. 83-86)
Archive all records per §4.2.5: F-414-001, F-739 (with DHF per FDA 21 CFR 820.30(j)), risk assessments, V&V reports, meeting minutes
Obtain final signatures & formally close change (Section J)
Quality Manager + Management Rep

⚠️ CRITICAL REQUIREMENTS:

  • Design Change Form (F-739): ONLY required for changes affecting product design AFTER Design Lock per ISO 13485:2016, §7.3.9
  • Independent Reviewer: MANDATORY for ALL design changes per ISO 13485:2016, §7.3.2 (not just FDA requirement)
  • Substantial Changes: Require Notified Body notification per EU MDR 2017/745, Article 120, Annex IX, §4.10 / EU IVDR 2017/746. Use MDCG 2020-3 Rev.1 assessment methodology
  • Risk Assessment: Required for changes affecting safety/performance per ISO 14971:2019
  • Phase 6.8: Skip to Phase 6.9 if Minor Change or no NB approval needed
  • Traceability: All changes traceable from initiation through closure per ISO 13485:2016, §4.2.5
  • Retention: Records retained per device lifetime + 2 years or per applicable regulations (FDA 21 CFR 820.30(j))
Pierre-Antoine Deglesne
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