Pre-Assessment Audit

Prior to a Quality Management System Certification, LNE/G-MED America offers manufacturers the chance to schedule a Pre-Assessment 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 Pre-Assessment Audit is a convenient, economical way for you to discover and correct any nonconformities, prior to the actual certification audit cycle. Your pre-assessment audit can be scheduled quickly and is completely confidential; only your company will receive audit results.

The Pre-Assessment 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 Pre-Assessment Audit is a great way to get early feedback on any issues you need to address and maximize your opportunity for successful certification.

Additional Value-Added Service Options

LNE/G-MED America provides a one-stop solution for your quality, training and testing needs. Our wide range of certification services and highly-trained auditors allow you to combine audits (such as for CE Marking and ISO 13485) to obtain cost-effective access to your desired markets.

In addition, our clients often take advantage of several other optional add-on services:

• On-Site Type/Design Examination
• NF Product Certification
• Fast-Track CE Marking
• Product and Component Testing

Advantages

LNE/G-MED is recognized to assess Active Implantable Medical Devices and has significant experience certifying a wide range of devices for CE Marking, often in conjunction with ISO 13485, CMDCAS, third party FDA inspection and other certificates, to save the time and cost of multiple audits.

You also benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485, ISO 14001) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

 

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team