IEC 62366-1:2015- Requirements, Process, Fees, Eligibility, Duration, and How Pacific Certifications Can Help
IEC 62366-1:2015 defines the usability engineering process for medical devices, focusing on minimizing use errors and improving user safety. It emphasizes designing medical devices that are effective, efficient, and safe to use, considering the needs and limitations of users. This standard is critical for manufacturers aiming to improve patient safety and deliver high-quality medical products to the market.
Understanding IEC 62366 Series
The IEC 62366 standard family consists of:
- IEC 62366-1:2015: Outlines the usability engineering process requirements.
- IEC/TR 62366-2:2016: Provides guidance on how to apply usability engineering to optimize the usability of medical devices beyond minimizing use errors.
Together, these documents help manufacturers design devices that not only comply with safety regulations but also enhance user satisfaction and overall performance.
Certification Process and Procedure
- Usability Planning:
- Develop a usability engineering plan aligned with device development stages.
- Identify intended users, uses, and use environments.
- User Interface Specification:
- Define all elements users interact with, including displays, controls, alarms, and packaging.
- Risk Analysis Related to Usability:
- Identify potential use errors that could lead to safety issues.
- Analyze and prioritize usability-related risks.
- Usability Validation Activities:
- Conduct formative and summative usability testing.
- Document results and verify that residual risks are acceptable.
- Implementation of Controls:
- Modify design elements or provide user training to mitigate identified risks.
- Internal Audits and Management Review:
- Review usability process effectiveness and compliance periodically.
- Certification Audit:
- Engage Pacific Certifications to conduct an external audit.
- Certification Issuance:
- Upon compliance confirmation, receive certification.
Documents Required for Certification
- Usability Engineering Plan
- User Profile and Intended Use Documentation
- Risk Analysis Reports (focused on use errors)
- User Interface Specifications and Prototypes
- Usability Test Reports (Formative and Summative)
- Validation Reports
- Corrective Action Records
- Internal Audit and Management Review Records
Eligibility Criteria
Manufacturers of medical devices that incorporate user interfaces impacting device safety and performance are eligible. Devices subject to FDA approval, CE marking under MDR, or similar regulatory pathways highly benefit from IEC 62366-1 compliance.
Certification Fees
Certification costs depend on device complexity, development stage, and usability system maturity. Contact Pacific Certifications at support@pacificcert.com for a customized quotation!
Certification Duration
The certification duration includes:
- Usability Engineering Process Setup: 3-5 months
- Testing and Validation: 2-3 months
- Certification Audit and Issuance: 1-2 months
Total process generally ranges from 6-10 months.
Requirements of IEC 62366-1 Certification
IEC 62366-1 mandates a structured usability engineering approach:
- Define Intended Use and Users: Clearly describe who will use the device and under what conditions.
- Identify Use Errors: Conduct risk analysis specific to user interaction and potential errors.
- Establish Usability Requirements: Define functional and safety-related usability goals.
- Develop User Interface Specifications: Create detailed documentation for all user interaction elements.
- Conduct Formative Evaluation: Test and refine the device design during development.
- Perform Summative Evaluation: Validate usability at the final stages to ensure risk control effectiveness.
- Implement Risk Control Measures: Modify device design to eliminate or reduce use-related hazards.
- Document and Maintain Usability Files: Maintain comprehensive records for regulatory inspection and quality assurance.
Benefits of IEC 62366-1 Certification
- Patient Safety: Reduces risks of harm from use errors.
- Regulatory Acceptance: Facilitates approval processes for FDA, CE marking under MDR, and other regulatory bodies.
- Device Usability: Leads to better user satisfaction and clinical outcomes.
- Liability Risks: Demonstrates proactive risk management through usability engineering.
- Market Competitiveness: Certification signals commitment to quality, innovation, and user-centered design.
- Efficiency: Streamlines design processes through structured usability practices.
- Market Access: Recognized internationally, easing entry into diverse regulatory jurisdictions.
Medical device manufacturers increasingly prioritize usability engineering due to evolving regulatory requirements, rising patient safety concerns, and demands for more intuitive healthcare technology. The focus is shifting from traditional functionality to designing devices that minimize cognitive and operational burdens for users, ensuring safer and more effective treatments.
How Pacific Certifications Can Help
Pacific Certifications supports organizations through the entire usability engineering certification journey:
- Expertise in regulatory expectations and real-world device usage scenarios.
- Accreditation ensures wide market acceptance of certifications.
- Guidance from planning through final audit stages.
- Assistance with maintaining usability compliance through surveillance audits.
To start your IEC 62366-1 certification journey, contact Pacific Certifications at support@pacificcert.com.
FAQs for IEC 62366-1 Certification
While not legally mandatory, it is highly recommended and often required by regulatory authorities to support device approval applications.
Yes, usability engineering processes can be incorporated into an organization’s ISO 13485 quality management system.
Formative evaluation focuses on improving design during development, while summative evaluation validates the final product’s usability.
Any medical device involving user interaction, especially those critical to patient safety, such as infusion pumps, ventilators, and diagnostic equipment.
The manufacturer must modify the device design or training materials to eliminate or mitigate the identified risk and revalidate if necessary.
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