ISO 13485 Training & Consulting for the Medical Device Industry

Our staff here at ISO Integration possess the knowledge and expertise necessary to help you ensure that your quality management system is up to par so that you can achieve your goals for certification. Many consider ISO Integration to be a prominent leader in the ISO (International Organization for Standardization) consulting industry. If you’re interested in the ISO consulting services offered by ISO Integration, read below.

Our ISO 13485 Consulting Services

The main goal of many organizations is to achieve ISO 13485 certification. ISO 13485:2016 requires that organizations demonstrate the ability to offer medical devices and services that fulfill both the needs of customers and regulatory requirements. Organizations that seek ISO 13485 certification are often involved in at least one product life-cycle stage, such as design and development, production, installation, storage, distribution, and more.

If your organization wants to attain ISO 13485 certification, you can count on ISO Consulting to help you implement, maintain, and improve your quality management system. One service we offer is gap analysis, which is often referred to as a preassessment audit. This gap analysis will help you strengthen your system by identifying weaknesses. We will then help you make improvements based on these identified weaknesses to ensure your quality management system will meet the standards for ISO 13485 certification.

Our professionals will be able to train your staff to fulfill ISO standards. ISO Integration offers a number of seminars and training courses for ISO 13485. Either your staff can come to us to participate in these public courses, or you can schedule a private training seminar on site. We will tailor our private training seminars to align with your organization’s objectives.

Why ISO Integration For ISO 13485?

The reasons you should choose ISO Integration over our competitors are numerous. Thanks to our almost 10 years of experience, we are considered a prominent leader in the industry of ISO consulting services. Since the conception of ISO Integration, we have grown and flourished so much that we are one of the biggest organizations in the world for ISO 13485 consulting and training. Without a doubt, we have the experience and knowledge needed to help you achieve ISO 13485 certification and boost the productivity, profitability, and efficiency of your organization.

ISO 13485 certification can help your organization better fulfill the needs and desires of your customers. Unfortunately, it can be difficult to attain ISO 13485 certification on your own. If you’re interested in the ISO 13485 consulting services we provide, you should contact ISO Integration to schedule an appointment and receive a quote. If you have any questions or concerns about the ISO consulting services we offer here at ISO Integration, don’t hesitate to contact us.

Author: Kim Cunningham
Kim has over 17 years of experience in quality as a Manufacturing Engineer, Quality Manager, and Quality Consultant. She has a broad spectrum of experience with multiple standards and regulations across various industries. Kim has strong working knowledge of the medical device and aerospace industries with experience auditing to ISO 9001, ISO 13485, AS9100, ISO 14001, and applicable regulatory requirements.
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How can ISO Integration help you? Please contact us to discuss our services and how we can assist you!


“…Kim Cunningham has provided Ahlstrom Nonwovens with detailed guidance and compliance checks for our ISO 9001 development. She is a critical part of our Quality Management System…”

– Ron Balaska, Production Manager
Ahlstrom Nonwovens, LLC