About Us
TEDMED Engineering and Projects was founded in 2011, as an independent consulting firm.
Our founder, saw the need to create a consulting firm that can support sponsors, and other stakeholders translate medical device ideas from the lab, and bench into commercial devices and to also assist scientist bring their drugs from preclinical, animal testing, human testing phases; all the way to commercial manufacturing. We provide services to assist with the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical research to ensure that regulatory guidelines for the safety of the human subject are followed.
We are contract, consulting and project to project clinical research and engineering firm. We provide clinical trial management and regulatory services. We work with Pharmaceutical, Biotechnology, Hospitals, Clinics, Research sites, CDMO, CMO, CRAMS, CRO and Medical Device companies.
We provide our clients the option to obtain our services on either project-by-project basis, contract, or consultants for the duration of the project.
We have developed and gained approval on numerous Class I, II, and III devices. We also own clinical research sites, and we perform phase II to IV study working with Sponsors, CRO's and investigator-sponsors.
Our clients return to us because we strive to exceed expectations. We are dedicated to bringing new medical products to market that are safe and effective for patients. We utilize our years of engineering, regulatory, and clinical expertise to support sponsors, who need help moving their product from concept to commercialization.
We support entrepreneurs, developers, and manufacturers of medical products through the entire product life cycle; providing services as needed from initial concept through product approval to post market needs.
We are also biotechnology engineers, we fix, perform preventive maintenance, validate, commission and qualify medical devices.
Mission
Patient safety is our mission.......
We take patient safety and project management approach to the services we provide to our clients. We know that medical devices are used on patients. Hence, we serviced it with thoroughness and quality.
We know projects are not permanent, it has a start and end date, and it should end with a very good outcome.
For a project to be successful, it needs to be well planned, managed, monitored, and controlled to meet stakeholders’ expectation.
We treat every service to our clients as a project that needs to be carefully managed, to achieve a successfully intended outcome.
We are also devoted to (D-C-P-M-A-R-A-R) in our research management. Thus, effective management of the design, conduct, performance, monitoring, auditing, recording, analyzing, and reporting of clinical trials. We utilize our expertise to promote patient safety in all aspects of the services we provide in healthcare medical device management, drug discovery, clinical trials management, medical device engineering and development, regulatory compliance, project management, and quality data management to ensure that all projects we managed are conducted with safety as the number one priority.
Vision
Our vision is to strive to exceed expectations by understanding our customers needs, requirements and expectations. We can only successfully exceed stakeholders expectation, when we listen and understand their needs and work to provide it.
It's our vision to keep stakeholders engaged and informed, so we can provide exactly what they require. We are the clients (Sponsor and CRO) representative.
Our Focal Point of Excellence
Our free training and education are focused on creating skillful research professionals, who utilizes advanced industry best practices to provide excellent service.
We are a devoted team of subject matter experts, whose combined intelligence is another means for TMEP customers to tap into our rich resources and years of collective experience in the industry.
Who we are
We have team of Biomedical Engineers, Biomedical Coordinators, Clinical Research Associates, Biomedical Managers, Project Coordinators, Project Managers, Clinical Research Project Managers, Validation Managers, Data Managers, Clinical Research Regulatory Directors among other industry titles.
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When you hire us, you get experienced professionals. We are knowledgeable and educated consultants with associates, bachelors and graduate education in Biomedical Engineering, Engineering management, Project Management, Clinical Research, and Regulatory Affairs. We have consultants and contractors who have ICH GCP training from ACRP, SOCRA, NIDA, and CITI and also GLP and GMP training.
We have a team of experienced Quality and Regulatory Managers with an extensive knowledge of FDA, EMA, DEA, ISO, IRB standards and regulations etc.
We continue to learn and train, to accommodate industry changes to better assist our clients.
TMEP is not just a Therapeutic Clinical Research Management firm, we are also a Medical Device Research and Engineering firm. We assist start up sponsors with the entire lifecycle of a Medical Device and Drug Research and Development. We work with FDA to classify your new device, assist with all other submissions and clinical research study.
Our regulatory knowledge and experience make us an asset to sponsors looking to speed up the submission process to product marketing. From device classification, 513g submission, IDE application, PMA etc.
We work directly with FDA on your behalf. We pride ourselves as experienced Clinical Research Professional among many other industry job titles. We are dedicated to the success of your most complicated research projects. We serve as SME.
