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ISO 9001:2008- Quality Management System

iso 13485 certification processThis standard specifies a set of procedures to demonstrate commitment to quality and ensure continual improvement and customer satisfaction.

Utilized by regulatory affairs professionals and quality managers throughout the world, ISO 9001: 2008 is applicable to all type of companies (manufacturers, services providers…) and industries.

 

 

 

 

 

 

ISO 9001 and its four goals

  • Enhance your company’s image and satisfy your customers
  • Demonstrate the efficiency of all your processes
  • Develop a quality organization focused on customer satisfaction
  • Increase staff involvement in your company’s objectives

The standard covers five main aspects:

  • Quality Management Systems
  • Management's Responsibility
  • Resource Management
  • Product Realization
  • Measurement analysis and continuous improvement

iso standards medical devices To request a proposal, Contact us.

 

MDSAP Prepare the transition, worldwide market access

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager