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Diagnostic Audit

Pre-Assessment Audit or Diagnostic Audit CertificationPrior to a Quality Management System Certification, LNE/G-MED offers manufacturers the chance to schedule a Pre-Assessment Audit or Diagnostic Audit. As an optional service, one of our auditors will visit your site to perform a mock audit prior to your actual Certification Cycle.

Benefits

The Diagnostic Audit is a convenient, economical way for you to discover and correct any non-conformities, prior to the actual certification audit cycle.

Your diagnostic audit can be scheduled quickly and is completely confidential; only your company will receive audit results.

The Diagnostic Audit:

  • Determines your readiness for certification by an actual registrar (LNE/G-MED)
  • Reveals your strong points as well as the weaknesses to clarify unmet requirements
  • Familiarizes your organization with LNE/G-MED and its auditors’ assessment method
  • Optimizes your resources by allowing you to focus on the gaps to be bridged
  • Applies to Quality Management System applicable standards, including:

- ISO 9001 General, ISO 13485 Medical Devices, ISO 15378 Primary Packaging Materials for Medicinal Products

- European directives for the CE marking of Medical Devices (MDD), Active Implantable Medical Devices (AIMD) and In Vitro Diagnostics(IVD)

- Canadian Regulation (ISO 13485 under CMDCAS program)

- Quality, Security and Environment (QSE) integrated management systems

If you are preparing for your first audit, have any concerns about your readiness or face critical deadlines, a Diagnostic Audit is a great way to get early feedback on any issues you need to address and maximize your opportunity for successful certification.

how to approve your certification for your product Contact us today.

Questions?

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

   1-301-495-0477

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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

Click here to Register


 

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

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

Click here to Register

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