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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.

Combo Training ISO13485 MDSAP

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 rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

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

2 days course 

Click here to Register