Regulatory Compliance for Medical Products

Capabilities

• In Vitro Diagnostics

  Exponent can help clients navigate challenges from refining clinical lab setup and operations to assisting with the development, manufacturing, or product launch for central lab, at-home, or point-of-care diagnostics. Exponent's multidisciplinary team understands the complexity of in vitro diagnostics product development and commercialization and can support clients throughout the total product lifecycle.

• Software as a Medical Device

  Software as a medical device (SaMD) development requires numerous complex challenges, including addressing evolving regulations and adapting with appropriate regulatory strategies. Exponent can independently review strategies for SaMD products, verification/validation plans for software, support regulatory submission efforts, and help you clarify health authority expectations and identify a path to market.

• Clinical Evaluation Reports

  Regulators globally are increasing expectations for clinical evaluation of medical devices, resulting in new requirements, particularly for higher-risk devices and implants. Exponent's experience with global regulators, clinical study design, clinical evaluation reporting and complementary data analysis methods can help clients develop comprehensive clinical evaluation reports ready for submission to regulatory authorities.

• Biocompatibility and Biological Risk Assessment

  Exponent's multidisciplinary approach helps clients navigate complex medical device regulatory challenges for medical devices and combination products with our wide range of expertise in biocompatibility, toxicology, and experience in biological or biosafety risk assessments.

• EU Medical Device Regulation (MDR) Compliance

  Exponent leverages our knowledge of EU Medical Device Regulation requirements and medical device industry experience to support developing, updating, and auditing technical file documentation for risk management, clinical evaluation, and post-market surveillance purposes.

• Contamination Control

  Sometimes a trace amount of unintended chemicals, particulates, or biological contamination can shut down a plant or cause a product recall. Exponent scientists and engineers bring extensive knowledge of relevant current good manufacturing practices and industry experience to support clients in identifying and remediating contamination issues in complex manufacturing settings. Exponent can help clients identify the appropriate structure, process, and controls to put in place to not only avoid potential issues but also to catch potential problems before realizing major impacts to production.

• Pharmaceutical & Biotechnology Manufacturing

  Whether introducing new delivery systems, manufacturing complex biomolecule entities, or resolving complex supply chain dynamics, innovation in pharmaceutical and biotechnology manufacturing can lead to uncertainty and multidisciplinary challenges.  Exponent engineers and scientists can help identify optimal strategies, science-backed supportive evidence, and bring multidisciplinary expertise to help manufacturers address the complexities that impact production of cutting-edge innovations.