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Regulatory and Technical Assistance

evaluation strategy and harmonized standards for conformity with safety and performanceFor the Medical Device Industry, innovating and bringing your device to a new market requires a clear idea of all the regulations to ensure you put the device on the right market, on time, and on budget. This milestone for success must include a clinical evaluation strategy and a clear regulatory and marketing path.

LNE/G-MED can guide you through these steps before you are ready for certification with our Regulatory and Technical Assistance service (RTA). This new, modular service is yet another tool in our comprehensive range of services to support you from the Design to the Production phase of your product.

Our Technical and Regulatory Experts will help you navigate the complicated Regulatory Schemes in three stages:

  1. Preparing a meeting based on the information you give us;
  2. Discussing with an Expert in your field based on a pre-established meeting agenda; and
  3. Preparing a meeting report within 15 working days following the meeting.

During these meetings, we can discuss such topics as:

  • Regulatory environment;
  • Defining “medical devices” with respect to a specific device;
  • Classification of Medical Devices;
  • Assessment procedures required for CE marking;
  • Clinical Evaluations Strategy;
  • Understanding the guidelines and recommendations from regulatory bodies (the “Borderline” manual, MEDDEV,….); and
  • Harmonized standards that are tools for the presumption of conformity with essential safety and performance.

The goal of LNE/G-MED’s RTA is to dedicate teams to a client in order:

  • To offer a wide range of services as a one-stop-shop to optimize our client’s time: LNE/G-MED’s multidisciplinary services assist customers through the entire lifecycle of a product, from design, to manufacturing, to after-sales services quality;
  • To have dedicated contacts and knowledge of the sector, expectations and business issues;
  • To bring more value to the client.

With LNE/G-MED’s RTA, you will have the opportunity to verify that your products can comply with regulatory requirements. In addition, you can have the applicable regulations, standards, and other documents with the guidance and comments of specialists in the field. LNE/G-MED can save you time and allow you to access the market faster by pointing medical device manufacturers in the right direction.

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

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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