Sterilization Process Validation — Process Package (ISO 13485)

Sterilization Process Validation — Process Package (ISO 13485)

€69.00

SKU ISO-26 Category Tags , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Process Package

Sterilization validation framework covering ISO 13485 §7.5.7, ISO 11135 (EO), ISO 17665 (steam), ISO 11137 (radiation), ISO 11607 (sterile barrier). Manufacturer reviews and approves supplier-provided documentation without duplicating.

What’s included:

  • SOP-ISO-26 Sterilization Process Validation — defines outsourced sterilization framework, supplier qualification (per F-ISO-22.x), supplier-provided VMP/IQ/OQ/PQ review, CoS (Certificate of Sterilization) review, ISO 11607 sterile barrier integration.

Why this package: Sterilization validation is heavily standardized — supplier expertise is essential. This SOP defines a clean review/approval framework without duplicating supplier documentation. Note: No templates in this package — sterilization providers supply their own per ISO 11135/17665/11137 accreditation.

Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.