Medical Device Regulatory Support
Regulation of medical devices covers the entire product life cycle, from conception to post-market surveillance. Exponent consultants help medical device manufacturers, contract manufacturers, attorneys, and others navigate the complex U.S. FDA and EU CE Mark regulations that govern the commercialization of medical devices. Our consultants provide technical support for premarket strategy, testing, and submissions; risk and hazard analysis; failure investigation; Corrective and Preventive Action (CAPA) and recall activities; FDA and Notified Body inspection and warning letter response; and litigation. Exponent’s multi-disciplinary consultants assist medical device manufacturers of all sizes, including virtual companies, with their medical device regulatory support requirements.
Risk Management. Managing risk is critical for medical device companies but can be overlooked early in the premarket stage of 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), CAPA plan development and implementation, and risk mitigation.
Submissions. Exponent’s consultants have decades of experience clearing U.S. FDA Class II and III medical devices in a number of therapeutic areas. Our engineers and scientists can also support client teams with clinical evaluation reports (CER), verification and validation test protocols and test summaries, clinical study design, pre-submission meeting preparation, and response to and interaction with FDA and Notified Bodies. Our consultants can support clients with assembly and submission of 510(k) or de novo submissions. With the new EU MDR, our team of multi-disciplinary consultants can support medical device clients with Technical Documentation preparation and review before CE Mark submission.
Compliance. Everyone in a medical device company contributes to regulatory compliance. Exponent can provide support with training, quality management system documentation, and 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, RCA, and CAPA planning.
Postmarket Surveillance. Exponent’s multi-disciplinary consultants 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.
Recalls. 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 an HHE, and implementation of a CAPA plan, including a root-cause analysis. Exponent’s multi-disciplinary consultants have extensive experience establishing and implementing recall procedures, assembling recall or compliance teams, interacting with FDA, and participating in recall-related HHE, CAPA, and RCA activities.
Failure Analysis. Exponent’s staff has decades of experience evaluating medical device failures, conducting retrieval analyses, and providing input to enhance product performance. Our engineers and scientists 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, electrical, chemical, and corrosion testing. Understanding potential failures throughout the product life cycle 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.