Regulatory

Given the complex regulatory framework that medical device and IVD companies need to work with, it is easy to make mistakes. This can significantly delay the market entry or result in the companies incurring unnecessary costs. With the help of Elexes, you can pursue the most optimal regulatory path to approval, successfully complete the registration for your device, and maintain compliance with worldwide applicable post-market requirements.

Regulatory Approval & Compliance Services

Regulatory approvals are mandatory to legally sell. Elexes has helped medical device and IVD companies expand their businesses by partnering with them to execute end to end approval and clearance processes. Some of the most common services that companies have benefited from while working with Elexes are as follows:

  • 510(k) Submissions
  • Letter to file (LTF) for changes to existing products
  • Appointment of a US Agent
  • Establishment registration & listing with the US FDA
  • PMA Submission
  • Investigational Device Exemption (IDE)
  • De Novo Submission
  • Emergency Use Authorization (EUA)
  • Breakthrough Device Designation
  • Review of marketing and advertising materials
  • Review of publications and other materials for compliance
  • Pre-submission meetings
  • Technical File for CE Marking
  • Health Canada MDL and MDEL
  • Australian TGA approvals
  • International Registrations

By leveraging our expertise and years of hands-on experience in solving intricate regulatory challenges, we design regulatory strategies that take your product to established and emerging markets worldwide in the most efficient manner. We provide strategies and execution in a very cost effective and timely manner.

Services in Pre-market:

Throughout the life cycle of a medical device or IVD product regulations are applicable. At the pre-market stage, it is important to be aware of testing, design, and other national and international requirements. It is also vital to ensure all these requirements are being considered by the product development team to ultimately facilitate the preparation of successful regulatory submissions. Elexes has been assisting with:

  • Predicate selection
  • Identifying testing requirements such as usability, safety, etc
  • Defining applicable ISO and IEC standards
  • Suggesting the tests per the IEC 60601 and other ISO/IEC standards
  • Selecting cost effective recognized test labs for testing
  • Holding cross functional meetings for software and design documentation
  • Acting as your point of contact for external parties involved in the submission
  • Leading the efforts of end to end submission preparation as a Project Manager

Services in Post-market:

Regulatory compliance and post market requirements become applicable once the IVD or medical device is in the market. You have to comply with various applicable requirements whenever you promote your product, perform marketing for your product, make modifications to the product, or service and refurbish the products. Elexes has been consistently helping companies maintain such compliances by assisting with:

  • Product modification notifications and documentation
  • Volume based complaint handling for various product lines
  • International regulatory updates
  • MDR transition
  • Reviewing advertising materials
  • Reviewing twitter, facebook, and other social media posts
  • Gap assessment and implementation
  • An integrated PMS system set up and maintenance

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