Medical Device Quality Management System | MANUFACTURING PLUS

SKU: MFG-PLUS
$3,599.00
$3,599.00
Unavailable
per item

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 PLUS

The 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.  

MANUFACTURING PLUS Quality Management System (QMS) Benefits

The Medical Device Quality Management System | MANUFACTURING PLUS 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. What makes this system 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. ​The quality management system streamlines 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.

MANUFACTURING PLUS Quality Management System Compliance

Our Medical Device Quality Management System | MANUFACTURING PLUS 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, ISO 10993, ISO 14155, additional FDA CFR’s, MEDDEV guidance documents, and more.
Download the QMS Content List with References to ISO 13485:2016 Clauses and FDA QSR Sections Here:
list_0001_manufacturing_plus.pdf
File Size: 186 kb
File Type: pdf
Download File
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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

K. Atwood

         
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Thank you so much for your kind support! You have provided the most fantastic QMS documentation we have seen available on the market. We are a suture manufacturer and the QMS package adds a great deal of value to our operation. 

​Khoa Do

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I often purchase products from A.P Lyon. I really appreciate the documents AND the service they provide (prompt response to my questions). I wish I discovered A. P. Lyon earlier!

​D. Marceau

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I'm very impressed with the quality system content. Very thorough, a perfect fit for a medical device company. Better system then any of the ISO 13485 companies I've been associated with.

​Tony Dedeo

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I purchased the QMS product designed for medical device designers. A.P. Lyon's procedures were very handy and easy to create a framework for our own unique products in literally a couple of months. Excellent product.

​Bal G.

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These QMS products are the real deal. We were up against a deadline for ISO 13485 certification and needed a solution. The A.P. Lyon products were just what we needed. The content is simple to understand but has a depth of content at the same time. The perfect balance and a solid product. Thanks!

​Cole Smith

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    Questions? Complete form for prompt response
  Call Us: 978.238.1245 
​  email: info@aplyon.com 

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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 DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING

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