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A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements (QSR) and compliance issues such as recalls, corrections, complaints, and medical device reporting (MDR).

Expert is experienced in guiding medical device clients with software and hardware requirements. The FDA requirements for validation of software products and the maintenance of development records are quite stringent. Medical device companies need to know these requirements early in their development planning to avoid costly delays.

Expert is well versed in requirements for verification and validation testing for stability and integrity of biomaterials. The testing, selection, qualification, and processing of these materials is critical to developing a safe device that will pass FDA and international regulatory review. Expert knows the ins and outs of ISO 10993 and other international testing requirements.

Expert is knowledgeable in the areas of specialized packaging materials, clean room technique (manufacturing), and sterilization procedures. Although not an "expert" in any one particular area, Expert is skilled in integrating clean room requirements, product requirements, manufacturer limitations, and OSR. Expert aids clients in identifying key clean room resources.

These devices require a full appreciation of the materials, manufacturing, clinical evaluation, and FDA application procedures, as well as reliability and retrieval issues. This is a highly developed field with extremely rigid FDA requirements and user expectations. Expert has a comprehensive working knowledge in this area, and can assist in avoiding common problems in new product development, or mature product management.

Expert has more than a decade of experience with providing submissions and supplements for a variety of devices. Her background includes a broad range of device categories and specializes in helping clients prepare submissions and all supporting documentation.

Expert has been instrumental in defining the clinical protocols and establishing clinical centers for testing materials and implants. Expert knows the requirements and regulations for testing new medical devices prior to approval. She works with clients to design clinical trials, monitor studies, and develop clinical assessment strategies to support regulatory submission.

Combination drugs and devices and biologics and devices require specialized strategic planning early in product development. It is critical to the medical device manufacturer that they understand the complexity of the submissions for these types of products. Combination products can be as simple as a drug on a catheter or as complex as an in-vitro diagnostic that involves a biologic, drug, and biomaterial medical device. Expert is proficient in the submission of combination products and can aid clients with early strategic planning.

Expert has been instrumental in defining the clinical protocols and establishing clinical centers for testing dental materials and dental implants. Furthermore, she is knowledgeable about FDA regulations for these devices and their biomaterials testing requirements.

Expert has developed a hazard analysis and risk assessment report template and spreadsheet that features many of the attributes of a failure modes and effects analysis spreadsheet, but which compiles with EN 1441 for risk analysis. This procedure, report template, and hazard analysis spreadsheet is well tested through numerous FDA submissions. Expert's skill in organizing hazard analysis teams within client companies and training client companies on the methodology have proven effective in early project planning and design control and review.