Medical Device CE Marking Procedure

Our quality management systems and individual procedures are configured for organizations engaged in the design and development of medical devices or the design and manufacture of medical devices.

Our quality management systems and individual procedures are ISO 13485:2016, MDR 2017/745 and FDA QSR compliant.  

Our medical device quality management systems and individual procedures have the critical building blocks to quickly introduce, train and develop a workforce in every aspect of medical device design, manufacture and post commercialization activities.

What makes our systems and procedures such an efficient and cost effective path to compliance is that companies can be 85-90% on their way to their compliance goals from day one.

Resources that would have been used to develop a system can now be shifted to implementation and supporting your business objectives.​

Our quality management systems streamline the practical application of core medical device regulations and incorporates medical device industry current thinking.

The content is straightforward, user friendly and refined over years of use.

Our medical device quality management systems, and individual procedures, comply with ISO 13485:2016, FDA 21CFR Part 820, MDR 2017/745 and other applicable standards such as ISO 14971, ISO 10993, ISO 14155, and more.

How long does it take to install the Quality Management System?

The quality management system (QMS) can be implemented in as little as 3-4 weeks. The major advantage of this quality system product is 85% of the work is already completed upon purchase. The remaining 15% is expended in aligning the quality system with your unique organizational structure, the markets you wish to serve, and quality system training.

Can the content be integrated with EQMS software?​

Yes! Many of our customers are using our products to either establish or augment their EQMS content. The procedures can be easily aligned with EQMS work instructions, workflows and forms.

Does A.P. Lyon provide support with quality system installation?

Absolutely!  Many of our clients will leverage our resources to either install the system or ask us to audit their quality management system (QMS) post installation.

How long does it take to obtain ISO 13485:2016 Certification?

Many companies that implement our ISO 13485:2016 quality systems are certified in as little as 3-4 months. The timing depends on the company's priorities and the ability to establish documented evidence they are indeed complying with the quality management system requirements.

Are the quality management systems FDA QSR Compliant?

Yes! Our quality management system iare FDA compliant and addresses the regulatory gaps between ISO 13485:2016 and the FDA QSR.

Have the Quality Systems been audited?

Yes! All of our quality management systems have been successfully audited by notified bodies, FDA, and been subjected to numerous third party audits.