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Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System (QMS) | MANUFACTURING PLUSThe Medical Device Quality Management System | MANUFACTURING PLUS is our "top line" and most popular QMS product developed for organizations engaged in both research and development and the manufacture of medical devices. The Quality Management System is configured for companies desiring ISO 13485:2016 and FDA QSR compliance.
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MANUFACTURING PLUS Quality Management System (QMS) Benefits
MANUFACTURING PLUS Quality Management System Compliance
Download the QMS Content List with References to ISO 13485:2016 Clauses and FDA QSR Sections Here:
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Frequently Asked Questions
How long does it take to install the MANUFACTURING PLUS 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. Is the MANUFACTRUING PLUS Quality System FDA QSR Compliant? Yes! This quality management system is 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. |
DO THE MATH
When you consider the hours required to develop a system internally or the cost associated with hiring an outside consultant to develop a quality management system for you we trust that you will see the value of our product offerings.
PRODUCT TESTIMONIALS
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I have purchased several of your products and I have always been happy with the quality of your work. Thanks for providing a great product.
Karen Atwood
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Map of Countries Served
RELATED LINKS
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN
Medical Device Quality Management System DESIGN PLUS
Medical Device Quality Management System MANUFACTURING
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The Medical Device Design and Development Procedures product contains multiple procedures related to the design and development of medical devices in accordance with FDA QSR and ISO 13485:2016 design and development requirements. This product is intended for companies needing procedures to augment their existing QMS to include design control and related content. All our procedures are ISO 13485:2016 and FDA QSR compliant.Quality Management System Manual
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The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
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- ISO 13485:2016 and FDA QSR Compliant
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- Digital Content - Instant Download