Published Jun 30, 2025 4 Min Read

ISO 13485: Meaning, Purposes, Importance, And Steps To Get It

 
 

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) tailored to the medical device industry. It ensures organisations consistently design, develop, produce, install, and service medical devices and related services to meet regulatory and customer requirements. Check your business loan eligibility if you’re planning to invest in compliance infrastructure to meet ISO 13485 requirements.

Key aspects include:

  • Dedicated QMS designed specifically for medical devices
  • Emphasis on consistent product quality and regulatory compliance from design through post-market stages
  • Integration of risk-based processes and documentation throughout the product lifecycle

What is the purpose of ISO 13485?

ISO 13485 was created to establish a consistent, regulatory-compliant QMS for medical devices. Its core goals are:

  • Ensuring adherence to legal and regulatory requirements for medical devices
  • Guaranteeing patient safety and device effectiveness through risk management
  • Maintaining product quality across every lifecycle stage
  • Building customer and stakeholder confidence in quality and compliance
  • Enhancing supplier oversight and overall quality documentation

Why is ISO 13485 important?

ISO 13485 is crucial because it:

  • Aligns organisations with global regulatory standards, including FDA and EU requirements
  • Improves product quality and patient safety by enforcing robust controls
  • Increases customer trust and satisfaction by consistently delivering high-quality products
  • Boosts operational efficiency through process optimisation and reduced errors
  • Opens up global market access and enhances brand reputation

Advantages of ISO 13485

Implementing ISO 13485 offers numerous benefits:

  • Strengthens regulatory compliance (FDA, MDR)
  • Ensures consistent product quality and minimises defects
  • Streamlines processes leading to efficiency and cost savings
  • Enhances brand reputation and builds trust in the market
  • Reduces the risk of costly recalls
  • Encourages a culture of continuous improvement and data-driven decision-making

How to get ISO 13485 certified?

The certification process typically involves:

  • Gap analysis of existing QMS against ISO 13485 requirements
  • Implementation or adjustment of QMS procedures, including risk management, traceability, documentation, and internal audits
  • Conducting internal audits and management reviews
  • Undergoing an external audit by an accredited certification body to confirm compliance
  • Addressing non-conformities, then receiving the ISO 13485 certificate
  • Maintaining certification through regular surveillance audits

Check your pre-approved business loan offer to fund costs related to certification, training, and audits efficiently.

Who is ISO 13485 applicable to?

This standard is applicable to organisations involved in:

  • Design, development, production, installation, and servicing of medical devices
  • Medical device manufacturers, their suppliers, service providers, and contract manufacturers
  • Companies needing compliance with regulatory regimes across regions including EU, US, Canada, Japan, and Australia

Conclusion

ISO 13485 is a comprehensive quality system standard designed specifically for the medical device sector. It enhances regulatory compliance, ensures product quality, improves operational efficiency, and provides global recognition—making it essential for any organisation involved in manufacturing, supplying, or servicing medical devices. For businesses looking to scale operations or invest in compliance infrastructure, exploring a business loan can support your certification journey.

Frequently Asked Questions

What does it mean to be ISO 13485 certified?

Being ISO 13485 certified means that an organisation has implemented a quality management system (QMS) that meets international standards specifically designed for the medical device industry. It confirms that the organisation consistently designs, develops, produces, installs, and services medical devices in compliance with regulatory and customer requirements, ensuring product quality, patient safety, and operational efficiency across the entire product lifecycle.

Is ISO 13485 mandatory?

ISO 13485 is not mandatory. However, the certification helps align with global regulatory standards, such as FDA and EU requirements, and is crucial for organisations involved in the medical device sector. This suggests that while not legally mandatory in all cases, ISO 13485 is often essential or expected for regulatory compliance and market access, especially in regions like the EU, US, Canada, Japan, and Australia.

What’s the difference between EN ISO 13485 and ISO 13485?

The core technical content of EN ISO 13485 and ISO 13485 is the same—both refer to the international standard for quality management systems in the medical device industry.

  • ISO 13485 is the global standard issued by the International Organization for Standardization (ISO).
  • EN ISO 13485 is the European adoption of the ISO 13485 standard, published with a European foreword and possibly minor annexes to comply with EU regulations.
    In essence, EN ISO 13485 is ISO 13485 with EU-specific recognition, making it important for medical device companies seeking CE marking or access to the European market.
How long does it take to get ISO 13485 certified?

Typically, the ISO 13485 certification process takes between 6 to 18 months, depending on:

  • The size and complexity of your organisation
  • The maturity of your current quality management system
  • Whether significant adjustments or implementations are needed
  • The time taken for internal audits, corrective actions, and external certification audits

Larger or multi-site companies may take longer.

Show More Show Less

Bajaj Finserv App for All Your Financial Needs and Goals

Trusted by 50 million+ customers in India, Bajaj Finserv App is a one-stop solution for all your financial needs and goals.

You can use the Bajaj Finserv App to:

  • Apply for loans online, such as Instant Personal Loan, Home Loan, Business Loan, Gold Loan, and more.
  • Explore and apply for co-branded credit cards online.
  • Invest in fixed deposits and mutual funds on the app.
  • Choose from multiple insurance for your health, motor and even pocket insurance, from various insurance providers.
  • Pay and manage your bills and recharges using the BBPS platform. Use Bajaj Pay and Bajaj Wallet for quick and simple money transfers and transactions.
  • Apply for Insta EMI Card and get a pre-approved limit on the app. Explore over 1 million products on the app that can be purchased from a partner store on Easy EMIs.
  • Shop from over 100+ brand partners that offer a diverse range of products and services.
  • Use specialised tools like EMI calculators, SIP Calculators
  • Check your credit score, download loan statements, and even get quick customer support—all on the app.

Download the Bajaj Finserv App today and experience the convenience of managing your finances on one app.

Disclaimer

1. Bajaj Finance Limited (“BFL”) is a Non-Banking Finance Company (NBFC) and Prepaid Payment Instrument Issuer offering financial services viz., loans, deposits, Bajaj Pay Wallet, Bajaj Pay UPI, bill payments and third-party wealth management products. The details mentioned in the respective product/ service document shall prevail in case of any inconsistency with respect to the information referring to BFL products and services on this page.

2. All other information, such as, the images, facts, statistics etc. (“information”) that are in addition to the details mentioned in the BFL’s product/ service document and which are being displayed on this page only depicts the summary of the information sourced from the public domain. The said information is neither owned by BFL nor it is to the exclusive knowledge of BFL. There may be inadvertent inaccuracies or typographical errors or delays in updating the said information. Hence, users are advised to independently exercise diligence by verifying complete information, including by consulting experts, if any. Users shall be the sole owner of the decision taken, if any, about suitability of the same.

Do more with the Bajaj Finserv App!

UPI, Wallet, Loans, Investments, Cards, Shopping and more