Emily Cannon Email & Phone Number

United States

Lakewood, Colorado

My primary responsibility is to write clinical evaluation reports (CER) for new and mature products requiring a CE Mark to market them outside the US. These documents require compliance with and knowledge of the European Commission MEDDEV 2.7/1 Rev 4 and the Medical Device Regulation, as well as collaboration with quality, marketing, research and development, engineering, and regulatory affairs team members is paramount.As the scientific, clinical evidence specialist for product CERs, I am responsible for assessing the safety and performance of the subject device specific to clinical performance, reviewing the failure modes and safety complaints of comparable devices and the subject device. The goal of the clinical evaluation report is to evaluate the safety and performance trends and demonstrate that the benefits of using the subject device out weigh any identified risks when the subject device is used as intended.As System Administrator, developed question sets with inclusion and exclusion criteria based the System Suitability and Data Contribution Criteria, and my extensive expertise in reviewing peer-reviewed literature for relevance according to MEDDEV 2.7/1 Rev 3. These question sets with inclusion and exclusion criteria were built into DistillerCER a systematic literature review software developed by Evidence Partners in Ottawa, Canada. This database provides traceability of the scientific subject matter experts responses as required by MEDDEV 2.7/1 Rev 4 and the new Medical Device Regulations.Co-presented “What is a CER, Why is it important to Terumo BCT?” to the Innovation, Research and Development Department, a meeting with more than 100 participants, including Regulatory, Engineering, Quality, and Scientific Affairs.

Austin, Texas Area

As a scientific evidence specialist, wrote CERs for new and mature products requiring a CE Mark to market them outside the US, in addition to compiling post-market surveillance plans. These documents required compliance with and knowledge of the European Commission MEDDEV 2.7.1 and MDD 93/42/EEC as well as collaboration with marketing, research and development, engineering, pre-clinical, and regulatory affairs team members is paramount, with strong literature review and analysis skills. My responsibilities included assessing the safety and performance of the subject device, reviewing the failure modes and safety complaints of comparable devices and the subject device, with the goal of evaluating the trends and demonstrating that the benefits of using the subject device out weighed any identified risks when the subject device was used as intended. Other responsibilities included working with organizational leaders and executive staff to develop global clinical development and scientific communication plans, assisting with the provision of evidence reports to the Safety and Efficacy Review Board of Smith & Nephew.

Austin, Texas Area

As a member of the Regulatory Affairs Department, which works closely with the R&D and marketing departments, I compiled clinical evaluation reports for the international oversight of the devices released outside the US. This involved a thorough literature review, a review of Medical Device reports, the MAUDE database and an assessment of device safety and intended performance of ArthroCare devices as well as equivalent competitor devices. In addition, I wrote the comparator device sections of several 510(k) submissions.

Austin, Texas Area

As a clinical project manager, my primary responsibility was to write the clinical evaluation reports (CER) for new and mature products requiring a CE Mark to market them outside the US. To accomplish my job, I familiarized myself with the European Commission MEDDEV 2.7.1 and MDD 93/42/EEC guidance documents; created a literature search protocol that included the clinical literature relevance criteria; and revised the CER template based on ever changing European Commission MEDDEV 2.7.1 and MDD 93/42/EEC guidance. Collaboration with marketing, research and development, engineering, pre-clinical, and regulatory affairs team members was paramount, as were strong literature review and analysis skills. As the scientific, clinical evidence project manager for product CERs, I was responsible for assessing the safety and performance of the subject device including clinical performance (either from clinical studies or clinical literature), reviewing the failure modes and safety complaints of comparable devices and the subject device. The goal of this document is to evaluate the trends and demonstrate that the benefits of using the subject device out weigh any identified risks when the subject device is used as intended.

Gaithersburg, Maryland

Moved IBT from the research and development (R&D) realm into a quality systems environment. As assay development expert, taught the assay development staff the process to follow when taking an assay from R&D to a qualified assay for use in preclinical and phase I clinical trials. Provided regulatory affairs expertise.

Bethesda, Maryland

Functioned as the Division of Microbiology & Infectious Diseases (DMID), Office of Regulatory Affairs (ORA) Good Laboratory Practice (GLP) regulations and bioanalytical assay expert. Assessed assay development and qualification according to the FDA's Bioanalytical Assay Validation Guidance and ICH Guidelines for multiple Centers for the Disease Control and Prevention (CDC) Category A agents and emerging diseases. Organized and led the Anthrax recombinant Protective Antigen (rPA) assay working group meetings and teleconferences to formulate strategy for development, validation and qualification of anti-protective antigen (anti-PA) Human ELISA and Toxin Neutralization assay (TNA). DMID assay consultant/auditor overseeing the successful technology transfer of the CDC validated anti-PA Human (hu)ELISA and TNA to five DMID contract sites. Prepared, submitted and managed documentation for studies ranging from non-clinical, pre-IND through Phase II clinical trials for DMID-held Investigational New Drug (IND) submissions and master files (MFs).

Frederick, Maryland

Provided current Good Manufacturing Practice (cGMP) Quality Assurance (QA) oversight and regulatory support within the Synagis manufacturing facility. Performed real-time QA review of the manufacturing process, from formulation of the growth media to storage of the drug substance prior to fill and finish.

Rockville, Maryland

Clinical sample coordinator and analyst for recombinant human (rhu) Endostatin and Angiostatin samples in support of INDs. Performed various immunoassays in support of preclinical research.