From concept to clearance…

We lead, support, or supplement your product development effort at all stages of the product lifecycle— we integrate seamlessly with your team to help make your products come to life.

Regulatory

We lead and support interaction and collaboration with the FDA related to your upcoming device submission. We have proven experience in navigating FDA regulations and obtaining FDA clearances in a streamlined manner.

Regulatory experts reviewing a 510(k) application

  • Determine your product code, FDA device classification, and approval pathway.

  • Complete all necessary forms, compile the data, perform gap assessments, submit to FDA.

  • Our team has direct experience in Class III device approval and navigating the IDE process.

  • No product code exists for your new device? We will lead the interaction with FDA to request a new product code.

  • We have experience with face-to-face meetings with the FDA. A Q-sub meeting can help ensure alignment with FDA on device classification, compliance requirements, and testing strategies.

  • A designation of Breakthrough Device from the FDA can fast-track your regulatory review and enable needed collaboration with the FDA— we can help.

Quality Management

We build Quality Management Systems custom-tailored to your company's product, size, and regulatory direction, and help ensure your QMS is audit-ready.

Custom Quality Management Systems for medical device startups

  • We develop your standard operating procedures that define your Quality Management System in compliance with FDA QSR and ISO 13485.

  • Evaluation of existing Quality Systems to determine areas of improvement, audit weakness, etc.

  • Whether an internal or external audit, we can partner with you to ensure a successful outcome and address findings to ensure full compliance.

  • Need help resolving findings from an FDA audit? We can help bolster your processes and fill the needed gaps to bring your Quality System up to par.

  • Train your team on how to make your Quality System work for you and encourage bottom-up Quality culture.

  • Ensure you select ideal suppliers in your supply chain to ensure success in early development and commercial launch. We perform site audits, supplier evaluations, and supplier corrective action requests.

FREQUENTLY ASKED QUESTIONS

  • We provide Regulatory Assessments for early stage devices to ensure the proper FDA product code is established, predicate devices identified, and FDA classification is determined to inform an appropriate regulatory strategy for the product development process.

  • Electronic Quality Management Systems (e-QMS) are helpful tools that can help facilitate timely document approvals, efficient document retrieval, etc. as your organization grows and product development progresses. However, many companies and clients are very successful early on with a fully paper-based system.

  • A Q-sub (or Pre-sub) meeting with the FDA is a process to receive formal feedback from the FDA for specific questions you may have in your device development. Often a Q-sub can be helpful if clarity is needed on topics such as device classification, testing strategy, or premarket clinical data requirements, though the process to prepare, present, and respond to a Q-sub can be lengthy. Not every device or project needs a Q-sub.