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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.

combo ISO 13485 9001

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 rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

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