Medical Device Design and Development Procedures

$1,899.00
$1,899.00
Unavailable
per item

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

  • 27 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
SKU: DESIGN

Medical Device Design and Development Procedures

The Medical Device Design and Development Procedures product was developed for organizations needing procedures to govern medical device research and development activity. The product is configured for companies desiring to establish or augment design controls and related procedures in their current QMS to gain ISO 13485:2016 and FDA QSR compliance.   ​

Design and Development Procedures - Benefits

The Medical Device Design and Development Procedures product has all the critical design and development related procedures to quickly introduce, train and develop a workforce in every aspect of medical device design activities. The product 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.

Design and Development Procedures - Compliance

Our Medical Device Design and Development Procedures will help the research and development 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 Clauses and FDA QSR Sections Here:
list_0001_design.pdf
File Size: 135 kb
File Type: pdf
Download File
COMPARE THE CONTENT OF ALL
​OF OUR QMS PRODUCTS

Frequently Asked Questions

How long does it take to install the Design and Development Procedures?
The DESIGN quality management system (QMS) procedures can be implemented in as little as 1-2 weeks. The major advantage of our procedures is 85% of the work is already completed upon purchase. The remaining 15% is expended in aligning our procedures with your unique organizational structure, and procedure 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 procedure installation?
Absolutely!  Many of our clients will leverage our resources to either install our procedures or ask us to audit their quality management system (QMS) post installation.

Are the Design and Development Procedures ISO 13485 and FDA QSR Compliant?
Yes! These procedures are both ISO 13485:2016 and FDA compliant.

Have the Procedures been audited?
Yes! Our Design and Development Procedures 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

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: [email protected]  

Map of Countries Served

RELATED LINKS

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

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