Regulatory strategy and quality management system (QMS) implementation are often two of the most challenging aspects of launching a medical device. The process can seem complex and overwhelming for new device developers and, unfortunately, there is no one-size-fits-all guide that defines the exact regulatory path for a specific device.

iFyber can help simplify the process to create and implement a manageable and cost-effective plan that makes sense for your specific product and business objectives. We work with you to define individualized strategies and act as an extension of your team to provide regulatory support during all phases of medical device development. Through assessments of your current and future operational goals, we aim to provide a tailored regulatory strategy and QMS that fits your organizational needs.

We understand the challenges of medical device development–what works for one company will not work for another. We believe conversations with regulatory agencies should happen early and often. Communication, paired with a critical examination of the required regulations, standards, and guidances, help our clients efficiently navigate the regulatory landscape with confidence.

 

What services can iFyber offer?

To legally market a medical device in the US, manufacturers must design, develop, test, and manufacture products according to Current Good Manufacturing Practices (cGMPs) and other applicable standards and guidances. In support of these efforts, iFyber offers individualized regulatory and quality consulting services, including strategy development, regulatory submission support, and Quality Management System development.

 

Regulatory Strategy and Consulting

  • Submission strategy development
  • Predicate identification for premarket notifications
  • 513(g) Requests for Information, device classification
  • Intended use and claims
  • Identifying applicable regulations and standards
  • Informational meetings with FDA

 

Regulatory Submissions and Post-market Activities

  • Pre-submission applications
  • Investigational Device Exceptions (IDE)
  • 510(k) Premarket Notifications
  • De Novo Petitions/De Novo 510(k)
  • Emergency Use Authorizations (EUA)
  • Additional Information requests
  • Post-market evaluation of device changes
  • Collateral materials and labeling

 

Quality Management System (QMS) Development and Support

  • Quality System Gap Analyses and Audits
  • Establishing QSR (21 CFR Part 820)/ISO 13485 compliant quality systems
    • Modifying quality system to include FDA/ISO requirements
    • Drafting manuals, policies, and procedures
    • NCR/CAPA procedures
    • Developing work instructions and process flows
    • Ensuring appropriate design, change, and document control
    • Internal Auditing
  • Design and Development Planning
  • Design History Files
  • Manufacturing documentation and design transfer activities
  • Validation master plans, SOPs, and protocols
  • Quality Assurance Support and Quality System Training

 

Why choose iFyber?

iFyber’s quality and regulatory consultants provide customized, actionable plans developed in collaboration with the agency and our sponsors.  Whether you need help writing sections of a 510(k) or a comprehensive regulatory strategy for a new device, we are an extension of your current team to provide high-quality deliverables quickly and communicate in a thorough and efficient manner. Our direct approach to managing the business risks quality and regulatory affairs produce differentiates iFyber from other consultants, and our sponsors and clients value that difference.

 

Contact our team today to discuss your quality and regulatory needs.

 

510(k) Data Packages

In addition to regulatory and quality consulting services, iFyber offers both standard and custom preclinical efficacy testing and data packages that can be submitted to FDA in support of a 510(k) submission.  iFyber offers both GLP and non-GLP compliant testing and we specialize in designing and executing customized test methods.

Frequently Asked Questions

What is a Pre-Sub?

A Pre-Sub is a formal written request for feedback from FDA that is in the form of written responses or feedback followed by a meeting. This meeting can be in-person or via teleconference. The program is entirely voluntary; however, FDA feedback may improve the quality of submissions, shorten review times, and facilitate a more effective development process.

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510(k) vs PMA vs De Novo – what is the difference?

  • A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device (predicate). A 510(k) must be submitted for Class I, II, and III devices that are not subject to a Premarket Approval (PMA)
  • A Premarket Approval (PMA) is the process by which FDA reviews the safety and effectiveness or Class III medical devices. A PMA is the most stringent device marketing application and requires extensive scientific and regulatory review.
  • The De Novo process can be used for novel devices of low to moderate risk that do not have a valid legally marketed predicate. Upon successful review of a De Novo request, FDA creates a classification for the device, a regulation if necessary, and identifies any special controls required for future 510(k)s of substantially equivalent devices.

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Why do I need a predicate device?

A predicate device is a legally marketed medical device that is used as point of comparison for new medical devices seeking 510(k) clearance. In order to receive clearance, the new device must be shown to be substantially equivalent to the predicate with regards to safety and effectiveness.

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What is design control?

Design controls are a set of quality practices and procedures outlined in 21 CFR Part 820 that control the design process to assure the device meets user needs, intended uses, and other specific requirements. Design controls apply to all Class II and Class III medical devices and some Class I. Often people refer to this as the point that research/feasibility ends, and design begins.