ISO 13485 is the de facto standard for medical device quality management systems (QMS). We have been helping companies implement, audit, or get trained on ISO 13485 since it was introduced in 1996. We leverage our proven approach for QMS development that combines planning, training, and follow-up consultation. Our goal is to ensure that all activities related to a successful ISO 13485:2016 quality management system are effectively implemented.
Need to upgrade your QMS? Our phased approach to ISO 13485 compliance will put you on the path to certification.
If you already have a limited QMS that complies with FDA regulations, we will first assess your current level of QMS compliance. This process will uncover opportunities for improvement and yield the information needed to make an informed assessment of the amount of time and resources required to comply with ISO 13485:2016. From here we will provide a detailed roadmap that will be used to prepare for your initial ISO 13485:2016 certification audit.
During the second phase (starting at Step 3 below) we will develop an action plan for you that will take you all the way to the point where you will be ready for your ISO 13485:2016 certification audit.
We deliver a harmonized QMS that meets US, European, and MDSAP market requirements.
ISO 13485 is not recognized by the US FDA. Instead, you’ll need to comply with the US Quality System Regulation, known more formally by its regulation number: 21 CFR Part 820. When we implement an ISO 13485:2016-compliant QMS for you, we also ensure you are meeting FDA QSR requirements, all in one seamless, cross-referenced QMS. As you grow and consider exporting to additional countries such as Australia, Brazil, Canada, and Japan, we can help you add procedures necessary to meet the specific additional requirements of those markets. That’s important, because if you sell in those markets, you will need comply with the Medical Device Single Audit Program (MDSAP). We can assist you with that.
Let our experienced ISO 13485:2016 consultants help you achieve certification.
For decades we have been training QA professionals on ISO 13485, implementing new systems, and auditing existing systems for ongoing QSR and ISO 13485 compliance. What distinguishes our approach is our focus on both performance and conformance. We use the certification process as an opportunity to analyze your processes with the goal of improving them before they are standardized and documented. While this approach may take slightly longer than others, the small investment of time will pay off with improved organizational performance. These recommendations provide a tangible ROI for your investment in a QMS.
Contact us today to learn how we can help you implement
ISO 13485:2016.