ISO 13485 — Medical Device QMS
Quality management system standard for organizations involved in medical device lifecycle.
Quick Facts
- Documents Included
- 14
- Category
- Healthcare & Life Sciences
- Regions
- Saudi Arabia / GCC European Union / UK United States
- Compliance Domains
- 5 domains
What's Included
SeedGovernance provides 14 ready-to-use templates for ISO 13485, covering 5 compliance domains. Each document is pre-filled with framework-specific guidance so you can start immediately.
Design Controls
Policies, processes, and evidence templates
Risk Management
Policies, processes, and evidence templates
Production Controls
Policies, processes, and evidence templates
CAPA
Policies, processes, and evidence templates
Supplier Management
Policies, processes, and evidence templates
How SeedGovernance Helps with ISO 13485
Beyond templates, our platform guides you through every step of ISO 13485 compliance.
Assessment Wizard
Answer guided questions to assess your ISO 13485 readiness and identify gaps.
Gap Analysis
Automatically surface what's missing from your ISO 13485 compliance programme.
Document Library
14 pre-built templates tailored to ISO 13485 requirements.
Operations Modules
Track incidents, changes, risks, and vendors — all mapped to ISO 13485 controls.
KPI Dashboard
Monitor your ISO 13485 compliance score in real time with automated metrics.
Auditor Access
Share a read-only view of your ISO 13485 compliance status with auditors.
Related Frameworks in Healthcare & Life Sciences
Organizations using ISO 13485 often also need these frameworks.
HIPAA
37 documents
US federal law protecting sensitive patient health information from being disclosed without consent.
FDA
41 documents
FDA regulations on electronic records and signatures in pharmaceutical and medical device industries.
EU MDR
18 documents
EU regulation governing the production and distribution of medical devices in the European market.
MHRA
16 documents
UK Medicines and Healthcare products Regulatory Agency framework for medical devices and pharmaceuticals.
GxP
14 documents
Quality guidelines and regulations for life sciences covering GMP, GLP, GCP, and GDP.
ICH GCP
14 documents
International standard for the design, conduct, and reporting of clinical trials involving human subjects.
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