ISO 13485
ISO 13485 Medical Device Quality
ISO 13485 is the internationally recognized standard for medical device QMS, ensuring organizations consistently meet customer and regulatory requirements throughout the device lifecycle.
Timeline: 6-12 months
Key Benefits
FDA compliance pathway
CE marking support
Enhanced patient safety
Regulatory approval
Market access
Industries Served
Medical Device Manufacturing
Diagnostics
Healthcare Technology
Life Sciences
Why Choose Exceleor for ISO 13485
Certified Lead Auditor
Certified ISO 13485 Lead Auditor with active contract auditor experience
Practical Implementation
Real-world, audit-ready systems designed for your specific operations
Lean Integration
ISO implementation combined with Lean Six Sigma for operational excellence
Transparent Pricing
Clear, upfront pricing with no hidden fees or surprises
Flexible Engagement
Full implementation, gap analysis, or retainer options available
Guaranteed Results
Committed to your certification success with ongoing support
Other ISO Standards
Ready to Achieve ISO Certification?
Schedule your free consultation today and discover how we can help you implement ISO standards efficiently and effectively.
Free initial consultation
Custom implementation roadmap
Transparent pricing
Guaranteed audit success