ISO 13485 Quality System Manufacturers | FDA QSR Compliant
This robust and proven ISO 13485 quality management system is for organizations engaged in both the development and manufacture of medical devices. The comprehensive quality system content has been continually refined over years of "real world" application. Each procedure is user-friendly to simplify the training process and encourage continued use. This system is by far the fastest path to ISO 13485 and FDA QSR compliance. Products installed in 20 countries and growing!
- Quality Management System Manual
- 65 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDD and MDR EU 2017/745 Compliant
- Implemented in as little as 4 weeks
- System Implementation Services Available
- Digital Content - Instant Download
- Available on CD Upon Request
ISO 13485 Quality System for Manufacturers
The ISO 13485 Quality System for Manufacturers was developed for organizations engaged in both the development and manufacture of medical devices. The quality system is for companies desiring ISO 13485:2016 and FDA QSR compliance. The system is a real time saver as it helps companies be 85-90% on their way to compliance from day one.
ISO 13485 Quality System Benefits
The ISO 13485 Quality System for Manufacturers has all the critical building blocks to quickly introduce, train and develop a workforce in every aspect of medical device design, manufacture and post commercialization activities. The system streamlines the practical application of core medical device regulations and incorporates medical device industry current thinking.
ISO 13485 Quality System Compliance
Our ISO 13485 Quality System for Manufacturers will help each department within the organization to comply with the regulatory requirements made part of ISO 13485:2016, FDA 21 CFR Part 820, MDR EU 2017/745 and other applicable standards such as ISO 14971:2012, ISO 10993, ISO 14155, additional FDA CFR’s, MEDDEV guidance documents, and more.
Frequently Asked Questions
How long does it take to install the ISO 13485 Quality System for Manufacturers?
The system 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.
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 system post installation.
How long does it take to obtain ISO 13485 Certification?
Many companies that implement our ISO 13485 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 system requirements.
Is the ISO 13485 Quality System for Manufacturers FDA QSR Compliant?
Yes! This system is FDA compliant and addresses the regulatory gaps between ISO 13485 and the FDA QSR.
Have the ISO 13485 Quality Systems been audited?
Yes! Our quality systems have been successfully audited by notified bodies, FDA, and been challenged by numerous third party audits.
Download the QMS Master List with References to ISO 13485 Clauses and FDA QSR Sections Here:
DO THE MATH
If you hire a company to create a QMS for you and they charge you $150 per hour. Do you think they could create a quality manual and 65 compliant procedure's with all supporting forms in 3 days? They would need to if they want to compete with us! We've done the work for you and we trust that you will see the value.
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