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How to Get ISO 13485 Certification? 10 FAQ
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How to Get ISO 13485 Certification? 10 Most Frequently Asked Questions

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Jan 25, 2024

13 min read

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

Introduction to ISO 13485 standard

ISO 13485 is a globally recognized standard that defines the requirements for a comprehensive quality management system in the design and manufacture of medical devices. This ISO standard plays a pivotal role in the medical device industry, serving as a benchmark for companies to ensure product safety, reliability, and quality.

The primary focus of ISO 13485 is on meeting both customer and regulatory demands, which are critical in this highly regulated sector. This standard provides a structured framework for manufacturers and suppliers to establish effective quality management systems, ensuring that their products consistently meet user needs and comply with applicable regulations. The significance of ISO 13485 standard lies in its comprehensive scope, covering aspects from product design to after-sales service. It is an essential certification for those involved in any stage of the medical device lifecycle.

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Why ISO 13485 certification is important?

Achieving ISO 13485 certification offers many benefits to organizations in the medical device field. By adhering to the requirements of this standard, companies can significantly improve their product development processes, leading to safer and more effective medical devices.

Additionally, this certification greatly enhances marketability, providing a competitive edge in both domestic and international markets. Compliance with ISO 13485 standard is often a prerequisite for doing business in many places in the European Union, and countries like Canada, or Australia, making it a key factor in global trade. Moreover, it plays a crucial role in building credibility and trust among stakeholders, including customers, regulatory bodies, and the public.

By demonstrating a commitment to quality and safety through ISO 13485 certification, companies can establish stronger relationships with these stakeholders, fostering confidence in their brand and products.

Additionally, ISO 13485 standard is becoming increasingly important for organizations in the medical device field, not only for enhancing product quality and marketability but also due to the ongoing harmonization with FDA regulations.

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FDA plans to harmonize QSR with EN ISO 13485:2016

The Quality Management System Regulation (QMSR) is the new regulation that aligns the ISO 13485:2016 standard with the FDA’s 21 CFR Part 820. This harmonization is a significant step toward regulatory simplicity and global alignment in the medical device industry. QMSR is expected to become effective in December 2024. This timeline is crucial for medical device developers and manufacturers who need to align their practices with these updated regulatory requirements.

For medical device manufacturers, it’s essential to understand that having ISO 13485:2016 certification will not exempt them from FDA inspection, and successful FDA inspections will not result in being awarded the ISO 13485:2016 certification. However, gaining ISO 13485 certification can aid in shaping a risk-based approach to Quality Management, which will be beneficial under the new QMSR.

As we’ve seen, ISO 13485 standard is crucial for ensuring quality in medical device manufacturing, aligning with international standards, and preparing for upcoming regulatory changes like the QMSR.

Now, let’s delve into the practical aspects and address the most common inquiries with the 10 most frequently asked questions on how to get ISO 13485 certification.

ISO 13485 standard

10 Most Frequently Asked Questions about ISO 13485 standard

1. What is ISO 13485?

ISO 13485 is a globally recognized standard that establishes guidelines for a Quality Management System (QMS) in the medical device industry. This standard is designed to ensure that medical device manufacturers create products that consistently meet regulatory and customer requirements. ISO 13485 standard covers all stages of a product’s life cycle, including design, production, installation, and post-market surveillance.

The focus of this standard is on risk management and risk-based decision-making processes, emphasizing the importance of maintaining effective control systems throughout the manufacturing process.

2. Why is ISO 13485 certification important for medical device companies?

ISO 13485 certification is crucial for medical device companies as it demonstrates a commitment to the quality and safety of their products. With the FDA aligning its Quality System Regulation (QSR) with the ISO 13485 standard, obtaining this certification becomes even more significant, especially as the proposed QMSR is expected to take effect by December 2024.

This alignment will streamline regulatory processes and ensure consistency with international standards, making it easier for companies to enter global markets. Furthermore, ISO 13485 certification helps in building customer trust and enhancing the company’s reputation in a highly competitive and regulated industry.

3. What are the steps to obtain ISO 13485 certification?

To get ISO 13485 certification, companies must first develop a QMS that meets the standard’s requirements. This involves establishing processes and procedures that ensure product safety and efficacy.

The next step is conducting internal audits to identify and correct non-conformities. Once these internal audits are completed, the company must fix any non-conformities found. The final step involves an external audit by a certified body, which will assess the compliance of the QMS with ISO 13485 standards. If compliant, the certification is granted to the organization.

4. How much does ISO 13485 certification cost?

The cost of ISO 13485 certification varies based on several factors such as the size and complexity of the organization, the extent of the existing quality management system, and the resources required for implementation and auditing.

Generally, expenses include:

  • ISO 13485 consultancy fees for setting up the QMS,
  • training costs to educate staff on the standard,
  • and fees for the certification audit.

Additional costs may arise from necessary changes in processes or equipment to meet the standard’s requirements. Small companies might have lower costs due to simpler systems, while larger companies may incur higher costs due to the complexity of their operations.

5. How long does the ISO 13485 certification process take?

The time frame to achieve ISO 13485 certification can vary significantly depending on the organization. For a company with a well-established quality management system, the process might take a few months.

However, for organizations starting from scratch or needing significant changes to their existing systems, the process can take over a year. Factors affecting the duration include the size of the organization, the complexity of the medical devices being produced, the current level of compliance with the standard, and the efficiency of implementing necessary changes. The commitment of the organization’s leadership and staff to the process also plays a critical role in determining the timeline.

6. Can a small company or startup obtain ISO 13485 certification?

Small companies and startups can indeed achieve EN ISO 13485 certification, which sets international ISO standards for medical devices’ quality management systems.

The EN ISO 13485 requirements are uniform across all organization sizes. Still, smaller businesses often have an advantage due to their simpler systems, which might be easier to align with the ISO 13485 standard. Achieving this certification can be particularly beneficial for smaller entities, establishing their credibility in the medical device industry.

To successfully navigate the process, small companies often seek guidance from ISO 13485 consultants who can provide an ISO 13485 overview and tailor the implementation to the company’s specific needs.

7. Is ISO 13485 certification required to sell medical devices globally?

While obtaining the ISO 13485 certification, which is a part of the ISO standards for medical devices, is not always a mandatory requirement globally, it is highly beneficial and often essential for market access in numerous countries.

As outlined in the ISO 13485 overview, this certification provides a framework for meeting various international and national regulations. It signifies a company’s adherence to the highest standards for quality management in the production of medical devices, facilitating smoother entry into international markets.

8. What are the major challenges in achieving ISO 13485 certification?

One of the primary challenges in achieving ISO 13485 certification involves comprehending and implementing the extensive ISO 13485 requirements. Developing a Quality Management System that aligns with the criteria set by the ISO 13485 standard for medical devices can be complex.

Maintaining ongoing compliance with these ISO standards for medical devices requires continuous effort and resources. Companies often turn to ISO 13485 consultants for expert guidance through this intricate process, ensuring that all aspects of their operations meet the necessary standards.

9. How does ISO 13485 certification impact product development?

ISO 13485 certification has a profound impact on product development in the medical device industry. The standard requires a systematic approach to product development, ensuring that every stage, from design to delivery, adheres to stringent quality and safety guidelines.

This approach reduces the risk of errors and non-compliance, leading to safer and more effective medical devices. It encourages companies to incorporate risk management and quality assurance processes from the earliest stages of product development. The standard also fosters a culture of continuous improvement, which can lead to innovative product enhancements. Ultimately, aligning with ISO 13485 requirements helps in building a robust product development process that consistently yields high-quality medical devices.

10. Can an individual get ISO 13485 certification?

ISO 13485 certification is an organizational certification, meaning it is granted to companies and not individuals. Individuals cannot be certified under ISO 13485; however, they play a critical role in helping their organizations achieve and maintain certification.

Employees at all levels contribute to implementing, maintaining, and improving the Quality Management System. Training and competency in understanding ISO 13485 requirements are vital for staff, especially those directly involved in product development and quality management.

While individuals cannot be certified, they can receive training and certification in ISO 13485 auditing or as a quality management professional, which can be instrumental in guiding their organization toward compliance.

Success in ISO 13485 certification is possible with the right partner

In conclusion, obtaining ISO 13485 certification is a crucial step for any organization involved in the medical device industry. It not only ensures adherence to the highest quality and safety standards but also prepares organizations for global market access and regulatory alignment, such as the anticipated QMSR.

While the journey to ISO 13485 certification demands a deep understanding and implementation of its requirements, the benefits it offers in enhancing product quality, marketability, and regulatory compliance are substantial.

If you’re venturing into the world of medical device software design and development, or if you’re on the path to setting up a compliant ISO 13485 quality management system, don’t hesitate to reach out to us at HTD Health.

We’ve successfully navigated the ISO 13485 certification process ourselves and are excited to share our insights and expertise with you. Let’s chat about how we can support your journey, making the complexities of the ISO 13485 standard more manageable and turning them into opportunities for your organization. Get in touch with HTD Health and explore together how we can bring your medical device projects to life, ensuring quality and compliance every step of the way!

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