Committed to creating bridges between
Medical Device Manufacturers and Markets

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Leilux Inc. is uncompromising in its pursuit of regulatory excellence for manufacturers and distributors of medical devices and in vitro diagnostics. The company was founded by Dr. Zafirios Gourgouliatos to serve the health care industry and has been assisting many clients since 2008. The company is also proud to be a trusted advisor to clients entering the national and international market places, from startups to large companies. Our commitment to these practices and industries reflects the founder's belief in focused proficiency paired with seasoned experience.

The company has a firm belief that a regulatory strategy has to be devised at the product concept phase and the proper execution of the strategic plan will avoid costly situations in the launching, installation, and lifetime of the product. A well thought strategy is a sound business practice for successful products and will satisfy Risk Management and other regulatory requirements. New technologies in uncharted territories, such as cell phones that can now function as medical devices, have introduced new challenges. Our company can assist in applying the basic fundamental principles that demonstrate safety and efficacy to facilitate regulatory clearance.

The company's professionals and associates provide clients with tailored solutions to their regulatory and business issues. Understanding the complex evolution and critical trends within these areas enables Leilux Inc. to provide clients with focused insight and deliver high-quality service and results. At Leilux Inc., client service is paramount, and we endeavor to meet and exceed our clients' expectations.

Leilux, Inc. can be instrumental in your effort to stay competitive and be ready for new opportunities. Whether you are a USA company that wants to expand abroad or an international company that wants to introduce products in the USA, an accurate roadmap is imperative. We can analyze your company's situation, evaluate how it is performing currently, and provide direction on what the company should be doing in the national and international fronts.

Client Service Commitment

We treat our clients as business partners. We listen attentively at all times to their concerns, stay highly responsive to their needs, and collaborate with them to produce results.

Communication is crucial to maintaining a close and cooperative relationship with clients. That's why professionals and associates of Leilux Inc. prioritize keeping clients informed about the status of their matters, new strategies, and industry developments. The firm ensures that every case and transaction is attended efficiently and that invoices are itemized clearly. We also regularly implement client feedback initiatives and follow up on the responses and suggestions. Even when we're not working on active matters, we stay in touch with our clients to add value in whatever ways we can.

Cutting-Edge Knowledge and Real-World Expertise

Global marketplace conditions change constantly. Barriers go down at a speed that is hard to keep up with, new regulations come into effect to harmonize rules and make them global. It is important for your company to respond quickly to these changes, maintain established positions and be ready for new opportunities.

Our professionals and associates stay at the forefront of developments in the industry by actively participating as members of professional associations. They also speak before civic, educational and business groups, and publish regularly in industry and business journals.

Our Services

  • FDA Registration
  • California FDB
    Registration
  • Risk Management
    (plan and execution)
  • 510(k) Submission
    (Pre-Market Notification)
  • Quality System Compliance
        Quality System Part 820
        Templates for small and
        large companies
        Quality System Implementation
        Quality System Audits
  • Crisis Management
        483 Responses
        Warning Letter Response
        Recall Assistance
  • International marketing
        Planning
        Distribution
  • Medical Device
    Safety Testing
  • Technical File
  • Pre-IDE Consulting
  • IDE (Investigational Device Exemption)
  • PMA
    (Pre-Market Approval)
  • Human Factor Study and Performance Testing
  • United States Agent/Official Correspondent Services
  • ISO Registration, CE Marking
  • DMEPOS Accreditation
  • DME/HCPCS Code
    Application
    HIPAA Compliance
  • Health Canada
    Registration
  • EU Representation

  

  

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