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Medical Device Quality Management System | DESIGN PLUS
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!
- Quality Management System Manual
- 46 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) | DESIGN PLUSThe 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 rich in content covering a broad range of subject matter related to medical device product development. The DESIGN PLUS quality management system includes proven procedures that have been challenged by the FDA and multiple Notified Bodies around the globe. The quality management system content complies with the requirements of ISO 13485:2016 and is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance.
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DESIGN PLUS Quality Management System (QMS) Benefits
DESIGN PLUS Quality Management System Compliance
Download the QMS Content List with References to ISO 13485 Clauses and FDA QSR Sections Here:
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COMPARE THE CONTENT OF ALL
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Frequently Asked Questions
How long does it take to install the DESIGN PLUS Quality Management System?
The DESIGN PLUS 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 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 quality management system requirements. Is the DESIGN PLUS Quality Management System FDA QSR Compliant? Yes! This quality management system is FDA compliant and addresses the regulatory gaps between ISO 13485 and the FDA QSR. Have the Quality Systems been audited? Yes! Our ISO 13485 quality management systems have been successfully audited by notified bodies, FDA, and been challenged by 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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RELATED LINKS
Medical Device Quality Management System BASE
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN
Medical Device Quality Management System MANUFACTURING
Medical Device Quality Management System MANUFACTURING PLUS
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