ISO 20417

ISO 20417:2021 is the internationally accepted standard that specifies information requirements for medical devices. It outlines the essential details that manufacturers must provide with a medical device, such as labels, instructions for use, and packaging information. These requirements are crucial to ensure safety, usability, and regulatory compliance across global healthcare markets.

As a globally recognized ISO certification body, Quality Asia Certification provides ISO 20417:2021 certification services to help medical device manufacturers demonstrate compliance with critical documentation standards.

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What is ISO 20417?

ISO 20417:2021 titled “Medical devices — Information to be supplied by the manufacturer” defines the minimum set of information that must accompany medical devices intended for human use. This includes:

  1. Labels (symbols, warnings, safety instructions)
  2. Instructions for use (IFU)
  3. Identification and traceability details
  4. Packaging and handling information
  5. Electronic documentation, where applicable

This standard ensures that all essential information is clearly provided to users, healthcare professionals, and regulatory bodies.

Why is ISO 20417 important?

In the highly regulated medical device industry, missing or unclear product information can lead to safety hazards, regulatory penalties, or product recalls. ISO 20417:2021 ensures that manufacturers adhere to standardized, globally accepted guidelines for providing essential product information.

Obtaining ISO 20417 certification through Quality Asia Certification:

  1. Establishes trust in product safety and usability
  2. Enhances readiness for audits and market approvals
  3. Aligns with EU MDR, FDA, and other global regulatory requirements


What are the benefits of ISO 20417?

  1. Guarantees uniformity and completeness in product labeling and instructions
  2. Reduces risks of misuse and operational errors
  3. Streamlines international product registrations and approvals
  4. Improves end-user confidence through clear and compliant product documentation
  5. Assists in meeting requirements of other related standards such as ISO 13485 and ISO 14971

What kind of businesses can benefit from ISO 20417?

ISO 20417:2021 certification brings measurable value to your business operations, regulatory strategy, and market access goals. Here’s how:

  1. ✅ Faster Regulatory Approvals – Speeds up submissions to authorities like EU MDR, US FDA, and Health Canada
  2. ✅ Market Expansion – Facilitates entry into international markets with standardized information compliance
  3. ✅ Reduced Product Recalls – Minimizes chances of documentation-related non-conformities or safety issues
  4. ✅ Strengthened Brand Reputation – Positions your company as a globally compliant and responsible medical device manufacturer
  5. ✅ Alignment with ISO 13485 – Complements your quality management system for medical devices
  6. ✅ Competitive Advantage – Demonstrates commitment to patient safety and regulatory excellence


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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