iso 13485

Elexes Regulatory & Quality Compliance Consultant

ISO 13485 Compliance

ISO 13458 is the globally recognized standard for medical device quality management that was published on February 25, 2016. The primary focus of ISO13485 was on quality management systems which is now used as a framework by all medical device regulatory programs including MDSAP.

What is ISO 13485 Standard?

The ISO 13485 standard provides a framework that is essential to demonstrate compliance to regulatory requirements. This standard is meant for manufacturers, designers, as well as suppliers in medical device industry. This framework while keeping medical device industry players compliant to regulations also mitigates the risks to stakeholders.

Our Expertise

Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.

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The basic goal behind ISO 13485 standard was to

Key elements of ISO 13485 Standard -

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Experience Team
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At Elexes Medical device consulting, we offer expertise in ensuring that your medical device manufacturing process and product itself stay compliant with the regulations.

We help with:

⦿ ISO 13485 certification readiness
⦿ ISO 13485 surveillance or recertification audit readiness
⦿ Pre-assessment audits
⦿ Gap analysis
⦿ Implementation of processes w.r.t. ISO 13485
⦿ Ensuring consistency between processes and practices

Our ISO 13485 experts will help you lay down the foundation of compliant procedures to be followed throughout the product development phase, saving a lot of money and time that otherwise will be spent on revisions.

Our Services

Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.


We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

A Trusted Team of Consultants

Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.

Local Language

Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.

Why Choose Elexes?


Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.

Local Regulatory Certification

At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.


We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.

Looking for assistance with your ISO 13485 certification?

If yes, our experts have years of experience to offer support for certification

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