On-Site Type/Design Examination

Interested in a more dynamic review process with real-time feedback? Then, On-Site Assessment may be an option for you in certain cases with your higher risk devices (Class IIb and III).

While technical file examinations are typically conducted remotely, manufacturers have the option to select an on-site assessment, where an LNE/G-MED reviewer will work directly at your facility with your qualified staff to access documents and review files.

Increased Efficiency and Valuable Staff Insight 

The on-site assessment option facilitates a greater level of communication and insight into the assessment process (type or design examination). Many manufacturers select this dynamic review process in order to benefit from:

• A potentially expedited review process, since communication speed is enhanced
• Dedicated access to an expert reviewer with instant feedback
• A valuable opportunity for an organization’s entire quality team to discover intricacies of the review process that improve organization of future files

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 services, such

• Pre-Assessment Audit
• 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