PathFree Technologies Corporation

Sally Dillehay – Extensive Experience in FDA/CE/ISO Regulatory Submissions, Quality Systems, and Clinical Trials for Medical Devices and Pharmaceuticals

Sally Dillehay is a highly respected professional with a wealth of experience in FDA/CE/ISO regulatory submissions, quality systems, and clinical trials for medical devices and pharmaceuticals. Her expertise extends to developing clinical literature reviews, evaluation reports, and data transition plans for MEDDEV and MDR submissions.

Professional Background

Sally Dillehay began her journey in the medical and pharmaceutical fields with a strong educational foundation. She holds advanced degrees in relevant disciplines, providing her with the theoretical and practical knowledge necessary for her career. Her academic background laid the groundwork for her expertise in regulatory submissions and clinical trials.

Entry into Regulatory Affairs

Sally’s entry into regulatory affairs was marked by her keen interest in ensuring that medical devices and pharmaceuticals meet the stringent standards set by regulatory bodies. Her early roles involved detailed work on FDA submissions, where she quickly became known for her meticulous attention to detail and comprehensive understanding of regulatory requirements.

Expertise in Regulatory Submissions

FDA Submissions

Sally Dillehay has an extensive track record of successful FDA submissions. Her deep understanding of FDA guidelines and her ability to navigate the complex submission process have been crucial in securing approvals for numerous medical devices and pharmaceuticals. Her work ensures that products not only meet regulatory standards but also reach the market in a timely manner.

CE and ISO Certifications

In addition to FDA submissions, Sally is proficient in CE marking and ISO certifications. Her knowledge of European regulations and international standards has enabled her to assist companies in achieving compliance with CE marking requirements and obtaining ISO certifications, which are essential for global market access.

Quality Systems Management

Development and Implementation

Sally’s expertise extends beyond regulatory submissions to the development and implementation of quality systems. She has played a pivotal role in creating robust quality management systems that ensure product safety and efficacy. Her work in this area includes the establishment of standard operating procedures (SOPs), quality manuals, and continuous improvement processes.

Audits and Compliance

Conducting internal and external audits is another area where Sally excels. Her thorough audits ensure compliance with regulatory standards and help identify areas for improvement. Her proactive approach to compliance has been instrumental in maintaining high standards of quality across various organizations.

Clinical Trials Management

Designing and Overseeing Clinical Trials

Sally Dillehay’s experience in clinical trials is extensive. She has designed and overseen numerous clinical trials, ensuring they are conducted in accordance with regulatory requirements and ethical standards. Her work in this area includes protocol development, patient recruitment, data management, and result analysis.

Collaboration with Research Teams

Her ability to collaborate effectively with research teams and principal investigators has been a key factor in the success of the clinical trials she manages. Sally’s leadership ensures that trials are conducted efficiently and produce reliable data that supports regulatory submissions and product approvals.

Developing Clinical Literature Reviews and Evaluation Reports

Comprehensive Literature Reviews

One of Sally’s core strengths is her ability to develop comprehensive clinical literature reviews. These reviews are critical in supporting regulatory submissions and providing evidence of product safety and efficacy. Her reviews are thorough, well-organized, and provide a solid foundation for evaluation reports and regulatory documents.

Evaluation Reports for MEDDEV and MDR Submissions

Sally has a proven track record in developing evaluation reports for MEDDEV and MDR submissions. Her reports are detailed and adhere to the specific requirements of these regulatory frameworks. Her expertise in this area ensures that submissions are complete, accurate, and stand up to regulatory scrutiny.

Data Transition Plans for MEDDEV and MDR

Strategic Planning and Execution

Sally’s experience in developing data transition plans for MEDDEV and MDR submissions is another testament to her strategic planning capabilities. These plans are essential for ensuring that all necessary data is accurately and efficiently transitioned to meet the latest regulatory requirements.

Ensuring Compliance and Efficiency

Her data transition plans not only ensure compliance but also enhance efficiency, reducing the risk of delays in the regulatory process. Sally’s approach to data transition is methodical and comprehensive, ensuring that all aspects of the regulatory requirements are addressed.

Impact on the Medical and Pharmaceutical Industries

Contributions to Product Approvals

Sally Dillehay’s work has directly contributed to the approval of numerous medical devices and pharmaceuticals. Her expertise in regulatory submissions, quality systems, and clinical trials has been instrumental in bringing innovative products to market, improving patient outcomes, and advancing medical technology.

Industry Recognition

Her contributions have not gone unnoticed. Sally is widely recognized in the industry for her expertise and dedication. She has been invited to speak at numerous conferences and has published several articles on regulatory affairs and quality systems management.

Conclusion

Sally Dillehay’s extensive experience in FDA/CE/ISO regulatory submissions, quality systems, and clinical trials for medical devices and pharmaceuticals underscores her importance in these fields. Her ability to develop clinical literature reviews, evaluation reports, and data transition plans for MEDDEV and MDR submissions highlights her comprehensive skill set and dedication to excellence. Sally continues to make significant contributions to the medical and pharmaceutical industries, ensuring that products are safe, effective, and compliant with regulatory standards.