Madelyn Gerber Email & Phone Number

Minnetonka, Minnesota, United States

Support international submissions by performing clinical evaluations, authoring post-market clinical follow-up plans and reports, and documenting summaries of safety and clinical performance. Curate clinical evidence and knowledge of state of the art. Contribute to clinical science strategic initiatives, including for new product development. Collaborate on post-market surveillance reports. Support marketing claims development.

Minnetonka, Minnesota, United States

Minnesota, United States

• Perform gap assessments and deliver guidance on biological safety evaluations for medical devices (per ISO 10993), with experience supporting compliance with EU MDR 2017/745 remediation.• Develop test plans, critically analyze data, and author expert appraisals of biocompatibility evaluations, reports, and justifications to facilitate device regulatory compliance and approval.• Provide sterilization support for medical devices, from engineering runs to process validation to routine processing (per ISO 14937, ISO 17665, ISO 11135, and ISO 11137).• Maintain up-to-date knowledge of ISO standards, MDD and EU MDR policies, and FDA regulations and critically review and report changes to internal and external stakeholders.• Maintain current knowledge of chemical compliance per REACH and RoHS standards and support risk assessments for marketing authorization holders.

Greater Minneapolis-St. Paul Area

In my role as founder of BioDiserta, I provide writing, proofing, and copy editing support to scientific and medical professionals. I leverage my extensive experience in biomedical laboratory research, project management, grant writing, poster and abstract preparation, and publication of peer-reviewed scientific research and review articles to provide high-quality support to clients at each step of the writing/publication process.

Greater Minneapolis-St. Paul Area

Columbus, Ohio Area

Laboratory of Lynne V. Abruzzo, MD, PhDDepartment of Pathology, The Ohio State UniversityResearch: Exploring the regulation and function of the genes NRIP1 and RUNX3 in chronic lymphocytic leukemia. Funded by the prestigious American Cancer Society Postdoctoral Fellowship.● Collected high-quality cell, tissue, and nucleic acid samples from clinical trial-enrolled patients and maintained long-term clinical health information on patient participants.● Managed, designed, implemented, and conducted biologically and statistically robust experiments on clinically relevant biomarkers.● Critically analyzed and interpreted data to compile discoveries and advance hematological research.● Published key findings in peer-reviewed journals to disseminate valuable discoveries to the public.● Presented research findings at local and national conferences to communicate complex scientific information to diverse audiences.● Clearly and efficiently conveyed the key scientific information to internal and external stakeholders.● Leveraged knowledge of relevant diseases and disease management protocols, healthcare environment, and competitors to articulate the medical and scientific value of our discoveries with external experts. ● Mentored and trained developing scientists in innovative, efficient, and responsible research practices.

Columbus, Ohio Area

Laboratory of Amanda Toland, PhDDepartment of Molecular Virology, Immunology, and Medical Genetics, The Ohio State UniversityResearch: Development of a cross-species, systems genetics approach for discovery of colon cancer susceptibility genes; identification of genes and variants underlying risk for colon cancer.● Recognized and collected feedback from multiple data sources, stakeholders, and key opinion leaders. ● Evaluated key insights from published studies and stakeholder interactions to improve research strategies and outcomes. ● Assessed emerging evidence in the industry to educate and enhance discussions with key stakeholders.● Collaborated with physicians in conducting research tests, monitoring progress, and reporting results in manuscripts, abstracts, and presentations.

Doctor Of Philosophy (Ph.D.), Biomedical Sciences, General, Recent Phd

Bachelor'S Degree, Biology, Psychology

High School