envelope  Contact us

phone1-301-495-0477

Product Certification

The purpose of Product Certification is to guarantee that a product meets the required standards following Conformity Tests and an ISO 9001 audit of the manufacturer's or distributor's Quality Management System. Once certified, products may carry a quality mark. Production Quality is subsequently monitored by means of Tests and regular Audits.

The NF Mark

Access to Europe market Product CertificationThe Voluntary NF mark verifies that Products or Services are compliant with the Safety and Quality characteristics as defined by specific International and Local Standards.

With tens of thousands of products bearing the NF mark, it is France’s Leading Product Certification Mark and is well known throughout Europe.

 

LNE issues the NF mark for over 60 product categories in a wide range of sectors:

  • Packaging,
  • Equipment for local authorities
  • Medical and Health products
  • Consumer products
  • Construction and Habitat
  • Energy and Environment

NF Mark for Medical and Health products

LNE/G-MED issues NF Medical Certificates under the Authorization of French Standardization Association AFNOR for a variety of medical and Health products including:

  • Surgical gloves
  • Toothpaste
  • Condoms
  • Lubricants
  • Medical beds
  • Therapeutic support surfaces
  • Operating tables and patient hoists
  • Other hygiene and Prophylactic products

This product certification may be done in conjunction with a Quality Management System Certification.

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

lne gmed arrow Submit a request

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