Regulatory Strategy and Planning

Navigate Regulatory Challenges for Seamless Product Launches

Companies often do not have the internal capacity or expertise to handle all aspects of regulatory affairs simultaneously. At AlvaMed, we balance regulatory risk with your business goals to provide strategic direction on complex regulatory challenges across all major markets. With experience in orthopedic, cardiovascular, SaMD, and therapeutic devices, we develop a plan for you to meet evolving regulations and standards and accelerate your product launch.

Define your product technology, accounting for any novel characteristics with a focus on the intended use.

Define the worldwide markets that are of most interest to support product adoption.

Review the device classifications for each chosen market to define the regulatory pathway.

Review currently available devices that validate the regulatory pathway and testing and/or clinical requirements. Create a summary of the information as a roadmap for gaining regulatory approval.

Based upon the strategic roadmap, develop a detailed plan for gaining regulatory approval.

AlvaMed has successfully supported the launch of medical devices in a multitude of global markets.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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Regulatory Strategy and Planning FAQ's

Regulatory requirements vary depending on the type and intended use of the medical device. Generally, key aspects include:

  • Classification: Understanding how the device is classified (Class I, II, or III).
  • Quality Management Systems (QMS): Implementing a QMS compliant with relevant standards (ISO 13485).
  • Labeling and Documentation: Ensuring accurate and compliant labeling and preparing essential documentation.

Navigating the regulatory pathway involves:

  • Device Classification: Determining the device class based on risk and intended use.
  • Regulatory Submissions: Identifying the appropriate submission type (e.g., 510(k), PMA, CE Marking) and preparing the necessary documentation.
  • Engaging with Regulatory Agencies: Establishing communication with regulatory authorities for guidance and clarification.

Essential documentation includes:

  • Technical Documentation: Comprehensive details about the device design, manufacturing, and performance.
  • Clinical Data: Data from clinical studies supporting the device’s safety and efficacy.
  • Quality Management System Documentation: Ensuring compliance with ISO 13485 and other relevant standards.
  • Risk Management Documentation: Identifying and mitigating potential risks associated with the device.

Eric Bannon

Senior Vice President

Eric has extensive experience in the start-up company environment to offer clients the strategic guidance to create an effective regulatory plan to guide interactions and submissions.

Schedule a meeting with Eric to discuss how AlvaMed can optimize your regulatory and strategy planning.