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Regulatory, Quality and Technical Training

Our experts use practical examples from their experiencesMake your team's performance skyrocket!

We offer a variety of training courses for Medical Device and In Vitro Diagnostics Medical Device Manufacturers.

We focus on your challenges and provide our attendees with a clear "take-home” value.

Utilized by Regulatory Affairs professionals and Quality Managers over the world, our programs are designed to ensure continual improvement and deliver practical tools.

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

All of our trainings feature

  • Customized training content and deliverables
  • Limited class size to ensure a high level of interaction
  • Hands-on practical case studies to encourage material retention and application.
  • Qualified Trainers and Experts for a gain of experience
  • In house or public training for your convenience


Training Portfolio


Picto ISO 13485 certification training course

Transition to ISO 13485:2016 Standard

Picto control of the sterilization process for ethylene oxide and radiation

Validation and Control of the Sterilization Process for Ethylene Oxide & Irradiation


Picto ISO 9001 certification training course

Transition to ISO 9001:2015 Standard

Picto Biological Evaluation, Biocompatibility of Materials training course

Biological Evaluation of Medical devices, Biocompatibility of Materials and Process


Picto Medical Device Software Lifecycle Processes training course

Medical Device Software Lifecycle Processes

Picto Electrical Safety and Electromagnetic Compatibility

Electrical Safety and Electromagnetic Compatibility (EMC) of Medical Devices


Picto Process Validation for Medical Devices training course

Process Validation for Medical Devices

Picto NF EN ISO 14971, Risk Management Applied to Medical Devices

NF EN ISO 14971, Risk Management Applied to Medical Devices


Picto In Vitro Diagnostics training

In Vitro Diagnostic Medical Devices

Picto European Medical Device Regulations training course

European Medical Device Regulations


Picto australia canada taiwan regulation training

Medical Device Regulation Australia, Canada, Taiwan

Picto ISO 14001 Environmental Management System training course

ISO 14001: The Environmental Management System


Customized Courses

Request a customized courseIf you have a specific training need not covered by our standard courses or you want us to adapt a training to focus on your specific products and needs, our staff can work with you to adapt or design a course.

Regardless of which type of training you choose, rely on LNE/G-MED America’s expertise to present courses that enable your entire team to make the smart decisions and establish sound business practices.

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Our Clients Say


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 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