Development & Testing
During the development and testing phase, assay design, analytical validation, and clinical validation are conducted to ensure accuracy, reliability, and alignment with regulatory expectations and accreditation requirements.
Regulatory Strategy and Regulatory Assessment
During the Development and Testing phase, it may be necessary to re-visit the regulatory strategy and assessment. If design changes to the test occur, those changes may affect the recommended classification, pre-market submission type, or predicate device. The regulatory landscape may have changed in the market(s) within scope. In that case, an outdated regulatory strategy can be lethal to a project. It’s imperative that regulatory strategies and assessments remain fluid and current to ensure the most expedited route to market for your test.
As part of the regulatory strategy, it’s critical to define the analytical and clinical validation necessary for the test. Depending on how the test is used Human Factors/Usability validation may also be required. Ensuring you have the right validation protocol designs will prevent unnecessary costs and delays. You do not want to have your premarket submission under regulatory agency review when you learn that the protocol wasn’t designed appropriately, or the sample size wasn’t large enough, for marketing authorization to be granted. Our team can help design, create, and execute these protocols, as well as analyze the data and create the reports, to facilitate efficient and successful premarket review.
Q-Sub
In the U.S., seeking FDA feedback through a Q-Submission at this stage is often recommended to align your development strategy with regulatory expectations. Early engagement with the agency can be critical for staying on schedule, managing costs, and de-risking your project. Covita Health Partners can help you leverage this process not only to gain regulatory clarity but also to strengthen your position with potential investors to assist in fundraising efforts.
Special Designations
Innovative medical technologies may qualify for special designations from the regulatory agencies, such as Breakthrough Device Designation, Safer Technologies Program designation, or Humanitarian Use Designation. Devices which qualify can enjoy the benefits of the designation, such as increased communication with the regulatory agency or a prioritized review. The designation must be received prior to the premarket submission. We can advise on if your device may qualify for any of these designations and help you secure it.
Quality Management System
During the Development and Testing phase, it’s essential to expand upon the quality management system (QMS) elements established during Ideation. Key additions at this stage often include supplier quality management, design controls, software development lifecycle (SDLC) processes, security risk management, and our Procedures for Purchase. Each are critical to ensuring a compliant and robust product development pathway.
Design History File and Risk Management
In most cases, a comprehensive Design History File (DHF) and Risk Management File (RMF) are essential components of your diagnostic test’s development. Covita Health Partners can help ensure these files are complete and compliant with applicable standards and requirements to streamline your premarket process, reduce the risk of delays, support a strong regulatory position, and set you up for success in an inevitable audit.
Electronic Records and Electronic Signatures
If you choose to incorporate electronic records and electronic signatures into your quality system, it’s essential to ensure compliance with regulatory requirements that safeguard their integrity, authenticity, and reliability. Selecting the right QMS software is equally important - an overly complex system can overwhelm your team and cause delays, while a limited platform may hinder your organization’s ability to scale effectively. Covita Health Partners can help you evaluate your needs, guide software selection, and ensure your implementation aligns with both regulatory expectations and your long-term growth strategy.
Inspection/Audit Readiness and Support
As you prepare for your premarket submission, it's equally important to get ready for key inspections and audits, including internal audits, supplier audits, mock and actual pre-approval inspections (PAIs), and ISO 13485 Stage 1 and Stage 2 certification audits. Our team brings deep regulatory compliance expertise to help you prepare with confidence, navigate the process efficiently, and support audit execution to achieve the best possible outcome. Laboratories can also lean on us to prepare for CLIA, CAP and other regulatory certification and accreditation audits.