ISO 13485 QMS-in-a-Box — Design-Only / R&D Entity

Design-only organizations are often forced into generic QMS models that overbuild manufacturing controls while still leaving Clause 7.3, DHF integrity, and design-transfer logic exposed. This design-only edition hard-locks Clause 7.3 expectations, DHF integrity, and design-transfer boundaries so teams can build an audit-defensible development system without unnecessary manufacturing content. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Governance and Use Guide.pdf
• Implementation Sequence.pdf
• Regulatory Role Definitions.pdf
• Clause Applicability Matrix.xlsx
• Mandatory vs Optional Records.xlsx
• Audit Exposure Risk Map.pdf
• Internal Audit Doctrine.pdf
• Internal Audit Framework.pdf
• Internal Audit Execution Checklists.pdf

Best suited to: R&D team, Startup manufacturer, Quality manager, and Regulatory consultant.

Useful in audit situations where you need to:

• Show a structured design-only ISO 13485 implementation process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to design-only ISO 13485 implementation.
• Support EU MDR technical documentation or quality-system reviews where design-only ISO 13485 implementation records need to be complete, controlled, and consistent.

Use this design-only edition to implement the right controls in the right order and present a cleaner design-control model to certification auditors and investors.