Medical Device Quality Management System | BASE SYSTEM

SKU: BASE
$1,899.00
$1,899.00
Unavailable

The ISO 13485 BASE Quality Management System (QMS) product contains procedures that serve as the foundation for your QMS needs. ISO 13485 and FDA QSR compliant. Products installed in 38 countries and growing!​

  • Quality Management System Manual
  • 23 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) | BASE

The BASE Quality Management System (QMS) is developed as a starter package for organizations engaged in the development and manufacture of medical devices. The BASE Quality Management System is configured to provide a solid QMS foundation that can be built upon for purposes of ISO 13485:2016 certification and FDA QSR compliance.  The system helps jump start companies efforts to implement a quality management system. Our BASE quality management system allows for content expansion and easy integration of any of our ISO 13485 Quality System Procedures should you wish to augment the BASE content at a later date.

BASE Quality Management System (QMS) Procedures Benefits

The BASE Quality Management System (QMS) 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 make our BASE quality management 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 quality management system can now be shifted to system implementation and your business objectives. The BASE 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.

BASE Quality Management System Procedures Compliance

Our BASE Quality Management System (QMS) 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, additional FDA CFR’s, guidance documents, and more.
Download the QMS Content List with References to ISO 13485 Clauses and FDA QSR Sections Here:
list_0001_base.pdf
File Size: 58 kb
File Type: pdf
Download File
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Frequently Asked Questions

DO THE MATH
How long does it take to install the BASE 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.

Is the BASE QMS product content ISO 13485 and FDA QSR Compliant?
Yes! This BASE quality management system content is ISO 13485:2016 and FDA compliant and addresses the regulatory gaps between ISO 13485 and the FDA QSR.

Have the Quality Systems been audited?
Yes! Our quality management systems have been successfully audited by notified bodies, FDA, and been challenged by numerous third party audits.
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.
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RELATED LINKS

Medical Device Quality Systems
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
​Medical Device Quality Management System MANUFACTURING PLUS

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