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LaunchWorksJun 23, 2023 9:58:27 AM2 min read

Regulatory Compliance: What You Need to Know About ISO 13485

To manufacture diagnostic and life science products, a Contract Development and Manufacturing Organization (CDMO) must be ISO 13485 certified to meet quality standards. These standards are developed by industry experts to help ensure that all products are manufactured safely and are created at a high level of quality to satisfy all users. Let’s explore some commonly asked questions about regulatory compliance and ISO 13485. 

What is ISO 13485?

According to the International Organization for Standardization (ISO), ISO 13485 outlines requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to manufacture medical devices, including In-Vitro Diagnostics (IVD), development and related services that consistently meet customer and applicable regulatory requirements. 

Although several countries have their own set of regulations regarding medical device design and creation, ISO 13485 is the main QMS standard for medical devices and is generally well accepted around the world. 

What Is the Value of ISO 13485?

To be ISO 13485 certified, an organization must be able to prove it has established and implemented documented processes that meet regulatory compliance standards. Additionally, the CDMO must pass a third-party audit of its documented processes. This is critical to the integrity and quality of medical devices because it guarantees consistency and traceability across products. 

An organization that is ISO 13485 certified is trusted to:

1. Document its requirements and the processes that fulfill those requirements.

2. Continually review its ability to meet those requirements.

3. Update its processes as necessary to maintain compliance with those requirements regardless of changes to external demands. 

This provides value for all parties involved in diagnostic product development as it is a fundamental practice required for agency approval. For the customer, it ensures that our organization monitors quality, continuously improves, and focuses on meeting regulatory requirements in parallel. 

What Regulatory Compliance Certifications Do Diagnostic Products Require?

As the owner of the medical device product, you are responsible for the product quality produced by your CDMO or sub-contractor. Your auditors will expect evidence of competency of your CDMO. 

By choosing a CDMO with ISO certification, you can rest assured that your auditor will be able to check off that you are meeting all necessary regulatory compliance requirements.  

How Easy Is It to Claim to Be “ISO 13485”?

In order to claim to be ISO 13485, the CDMO must first be certified. This requires examinations by an accredited third party, such as BSI or TÜV, and includes annual audits of all aspects of the design and development processes. 

How Do I Determine if a CDMO’s ISO 13485 Is Adequate?

Generally, the longer a company has been certified, the more mature their quality system. A mature quality system typically results in a more efficient and low-risk onboarding process. The most recent revision to ISO 13485 occurred in 2016 and included specifications regarding risk, management and training responsibilities, as well as product cleanliness standards. 

Understanding the basics of ISO 13485 can help you choose the right CDMO to develop your product. LaunchWorks is a CDMO that is ISO 13485 certified and FDA registered. From initial product development to quality control testing to fulfillment needs, we will be there every step of the way to ensure that all final products are ready for commercialization. Get in touch with our team of experts today to learn more about product development and manufacturing. 


LaunchWorks is a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget.