Ensure Regulatory Compliance with ISO 15378 Certification

For medical device manufacturing startups in the USA, ISO 15378 certification serves as a strategic benchmark to ensure that primary packaging processes comply with global quality and safety standards. This international standard integrates ISO 9001 with Good Manufacturing Practices (GMP), supporting alignment with FDA expectations and other regulatory requirements. 

Importance of ISO 15378 for Medical Device Packaging

Primary packaging plays a critical role in safeguarding medical devices by preserving sterility, integrity, and functionality. ISO 15378 establishes a robust framework to minimize contamination risks and promote consistent packaging performance—an essential factor for startups seeking regulatory approval and build long-term credibility in the medical device market. 

ISO 15378 Certification

Importance of ISO 15378 for Medical Device Packaging

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Key Benefits of ISO 15378 Certification:

  • Regulatory Readiness: Facilitates compliance with FDA and international GMP standards for packaging of Class I, II, and III medical devices. 
  • Enhanced Product Safety: Reduces contamination risk and preserves the integrity of primary packaging throughout the supply chain. 
  • Operational Efficiency: Promotes standardized processes that reduce waste, improve traceability, and support lean manufacturing. 
  • Competitive Advantage: Signals a commitment to quality and safety—key differentiators when engaging with healthcare providers, distributors, or global buyers. 
  • Business Growth: Increases credibility with stakeholders, regulatory bodies, and potential partners by demonstrating a certified quality system. 

ISO 15378 Certification Process for Medical Device Packaging Startups

Operon Strategist provides end-to-end support for ISO 15378 certification tailored to startups operating in the United States medical device industry: 

  1. Gap Assessment (Optional): A comprehensive gap analysis is conducted to evaluate current packaging practices and quality systems, identifying areas for improvement prior to the certification audit.
  2. Stage I – Documentation & Process Review: Initial assessment of quality management documentation and on-site procedures to confirm alignment with ISO 15378 requirements.
  3. Stage II – Certification Audit: Detailed evaluation of system implementation, risk controls, traceability, and adherence to GMP guidelines specific to primary packaging for medical devices.
  4. Certification & Continued Compliance: Following successful audit completion, ISO 15378 certification is awarded. Ongoing support is provided for surveillance audits and maintenance of compliance.

Why Choose Operon Strategist?

Operon Strategist offers regulatory and quality system consulting tailored for emerging medical device manufacturers. With global experience and in-depth knowledge of ISO standards and FDA regulations, the team assists in achieving packaging compliance efficiently and effectively. 

  • Expertise in US Medical Device Regulations 
  • Proven Success in ISO 15378 Implementation 
  • Tailored Solutions for Early-Stage Manufacturers 

Start the ISO 15378 Certification Journey

Partner with Operon Strategist to build a foundation of trust, quality, and regulatory readiness in medical device packaging. 

📩 Contact Operon Strategist for a consultation or project inquiry

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