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Medical Device Regulatory Compliance & Recall

Overview


How well a company manages a recall situation or deals with regulatory non-conformity matters, as outlined in a 483 or FDA Warning Letter, 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, and implementation of a Corrective and Preventive Action (CAPA) plan, including a root-cause analysis. A firm’s success in interacting with FDA and communicating with health-care professionals, the media, the public, and its own employees can have a major impact on future perceptions of the company and possible liability. In addition, determining whether a device failure occurred, and identifying and correcting its cause, are key to getting a product back on the market after a recall.

Exponent has broad experience across the medical-device industry in conducting root-cause and risk analyses as part of CAPA procedures. We are well positioned to review your internal standard operating procedures for quality control, inspections, validation, qualification, investigations, root-cause analyses, and CAPA planning, and assessing the impact of the observations noted by FDA. With the participation of Exponent’s statisticians and data analysts, we can also evaluate the trending practices being used to track non-conformances, as well as to enhance the procedures to control and monitor non-conforming products. Well-managed recalls and responses to 483s and FDA Warning Letters are not usually “an accident,” but rather are the result of extensive preparation ahead of time in terms of Standard Operating Procedures (SOPs), compliance with Good Manufacturing Practices (GMPs), and assembling a recall or compliance team with all the right capabilities and experience. Exponent has extensive medical, engineering, scientific, and regulatory expertise to assist medical device companies in handling these situations.

Exponent’s staff has many years of experience in evaluating medical device failures 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.

Corrective and Preventive Actions (CAPAs)

Exponent’s staff has extensive experience in conducting root-cause analyses for medical devices, as well as reviews and evaluations of device history records (DHRs) and SOPs as part of CAPA programs.

Manufacturing

Exponent provides GMP expertise, manufacturing operations support, manufacturing process analysis, trouble-shooting and process FMEA, as well as process verification, validation, and statistical process support.

Health Hazard Evaluations

Our staff of health scientists, with expertise in risk and exposure assessment, has experience in conducting health hazard evaluations. Working with our engineers, our experienced medical and scientific staff can help provide an understanding of the health and safety implications of device failures.

Medical Device Reporting (MDR)

Exponent’s physicians and epidemiologists have experience in the medical evaluation of adverse-event reports and trend analysis, as well as experience in evaluating SOPs for MDRs.

Regulatory

Exponent has experience in working with regulatory teams within companies to assist in developing plans to approach and interact with FDA.