ISO 13485 Consulting Services

As a medical device manufacturer, it is important to ensure you are in compliance with all rules and regulations you face in the industry. Whether you already have your business built up or you are starting your business now, focusing on ISO 13485 takes a lot of time to set up and maintain. Our ISO 13485 consultants are in the business of helping with this compliance system so your business can be successful through our ISO 13485 Consulting services.

What Is ISO 13485 and how ISO 13485 Consulting Can Help

ISO 13485 is a Quality Management System (QMS) that is designed to help you maintain your quality practices and ensure that both your information as well as any patient information is secure. It is designed for medical device companies and is a very common choice for many companies who need to meet QMS requirements in various countries all over the world. Being ISO certified with the help of a ISO 13485 Consultant ensures that you can manufacture and market you devices, specifically Class II or any higher risk classification device, outside of the United States. It ensures that you maintain higher efficiency with a higher quality product. ISO 13485 Consulting can also help you improve your customer service to your customers. It shows commitment to quality which will make your products eligible to compete with others in the market. You will have more credibility with potential and current customers and you will be meeting the minimum compliance requirements for a large number of markets across the globe.

How Can We Help With ISO 13485 Consulting?

Our ISO 13485 Consulting services help you to attain this certification while still working on your business day to day. Your business will not suffer as a result of you attempting to implement this certification because our consultants will do the majority of the work for you. We work closely with you to ensure your budget is maintained as well as the timeline you have set forth. Our ISO 13485 Consultants work with medical device manufacturers so we are aware of the unique situations you may face. Your system will meet the needs of the industry while also meeting the needs of your unique business. As your ISO 13485 Consultant, we will ensure that you are always ready for a certification audit after your certification has been approved. We come to you and work on site to develop the system and train employees on how to properly execute it after our work is completed. This is an integral part of the success you are seeking and will help you maintain the system for years to come. Additionally, our ISO 13485 Consultants offer third party testing to ensure the system we have developed works as it should for your specific business and the overall quality requirements of the industry.

If you are ready to become certified and open your business to more markets around the world, contact our ISO 13485 Consultants today.

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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