Medical Device Regulatory Support
Regulation of medical devices covers the entire product lifecycle, from conception to post-market surveillance. Understanding and implementing regulations requires resources and expertise. Exponent consultants assist medical device manufacturers, contract manufacturers, attorneys, and others navigate the complex US FDA and EU CE mark regulations that govern the commercialization of medical devices. Our consultants provide technical support for pre-market strategy, testing, and submissions; risk and hazard analysis; failure investigation; CAPA and recall activities; FDA inspection and warning letter response; and litigation. Exponent consultants from a variety of practice areas assist medical device manufacturers of all sizes, including virtual companies, with their medical device regulatory support requirements.
Risk Management. Managing risk is of primary importance for medical device companies, but can be overlooked early in the premarket stage of device development. Exponent’s consultants have extensive real-world experience establishing risk management programs for medical device companies. Our staff can assist with Risk Management (per ISO 14971), Failure Modes and Effects Analysis (FMEA), failure testing, Health Hazard Evaluation (HHE), Root Cause Analyses (RCA), Corrective and Preventive Action (CAPA) plan development and implementation, and risk mitigation. We can also assist companies needing to respond to FDA or other regulatory agencies regarding the risk management of their devices. Working with our engineers, our experienced medical and scientific staff can help provide an understanding of the health and safety implications of potential device failures.
Submissions. Exponent’s Biomedical Engineering consultants have decades of experience clearing Class II and III medical devices in a number of therapeutic areas. Our engineers and scientists can assist with clinical evaluation reports (CER) literature reviews, verification and validation test summaries, clinical study design, pre-submission meeting preparation, response to and interaction with FDA, and assembly and submission of 510(k) or de novo submissions. Our regulatory consultants can walk clients through the entire submission process or provide technical or regulatory support as needed.
Compliance. Everyone within a medical device company contributes to regulatory compliance. Exponent can provide support with training, quality management system documentation, response to FDA 483 observations or Warning Letters. Our staff can also review your internal standard operating procedures for quality control, inspections, validation, qualification (IQ, OQ, PQ), investigations, root-cause analyses, and CAPA planning. Maintaining a compliant organization contributes to the safety and effectiveness of devices, risk management, and overall efficiency of company operations.
Postmarket Surveillance. The regulatory requirements for a medical device continue after the device is on the market. Ensuring the safety and effectiveness of a medical device requires a comprehensive postmarket surveillance program including complaint handling, medical device reporting (MDR), and trending analyses. Postmarket activities may also include publications and analysis of data collected in postmarket device registries or under FDA imposed 522 Orders. Exponent’s statisticians and epidemiologists can assist with development and implementation of postmarket surveillance programs, including FDA mandated 522 Postmarket Surveillance Studies. We can also evaluate trending data related to non-conformities, and assist with enhancement of procedures used to control and monitor non-conforming products. In addition, our scientists and engineers have published widely, and are available to co-author publications to highlight the performance of your device in premarket or postmarket settings.
Recalls. How well a company manages a recall situation can affect not only the future viability of the product, the company’s liability, and financial loss, but can also affect a company’s good name, reputation, and "brand equity." Reaching a decision to recall a product, and conducting the recall, requires careful evaluation, including analysis of adverse-event reports, identification of the specific products or lots of products to be recalled, execution of a health hazard evaluation (HHE), and implementation of a Corrective and Preventive Action (CAPA) plan, including a root-cause analysis. Exponent’s consultants have extensive experience establishing and implementing recall procedures, assembling recall or compliance teams, interacting with FDA, and participating in recall related Health Hazard Analyses (HHA), CAPA, and Root Cause Analysis (RCA) activities.
Failure Analysis. Exponent’s staff has decades of experience in evaluating medical device failures, conducting retrieval analyses, and providing input to enhance product performance. Our engineers have performed materials characterization and selection, finite-element and stress analysis, engineering and fracture mechanics, fatigue evaluations, fluid-flow and diffusion analysis, vibration and acoustic testing, biomechanical and ergonomic evaluation assessment, and physical, mechanical, chemical, and corrosion testing. The utility of failure analysis is not limited to the postmarket stage of a product. Understanding potential failures throughout the product lifecycle can lead to more comprehensive risk management, enhanced product performance, and acquisition of data that may be useful for FDA or CE mark submissions or response to regulatory agency inquiries.
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