ISO 13485 Quality System Specification Developers | FDA QSR Compliant
The ISO 13485 quality management system product is specifically designed for companies engaged solely in the design and development of medical devices. The content of each procedure has been refined over years of practical application. The system is very user-friendly and is the most efficient and cost effective path to ISO 13485 and FDA QSR compliance on the market. Products installed in 24 countries and growing!
- Quality Management System Manual
- 53 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Implemented in as Little as 4 Weeks
- Developed from an R&D Perspective
- System Implementation Services Available
- Digital Content - Instant Download
- Available on CD Upon Request
ISO 13485 Quality System for Specification Developers
The ISO 13485 Quality System for Specification Developers was developed for companies engaged in the design of medical devices but do no manufacturing. What make our systems 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.
ISO 13485 Quality System Benefits
The ISO 13485 Quality System for Specification Developers has all the critical building blocks to quickly introduce, train and develop a workforce in every aspect of medical device design, development 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
The ISO 13485 Quality System for Specification Developers helps each department within the organization to fully comply with 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 Specification Developers?
The system can be implemented in as little as 4-6 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 quality 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 Specification Developers 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 Content 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 53 compliant procedure's with all supporting forms in 21 hours? They would need to if they want to compete with us! We've done the work for you and we trust you will see the value.
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