TEDMED ENGINEERING & PROJECTS

We are an established Clinical Research and Development consultants (CRDO).  We are also a Medical Device Engineering firm.  We offer validation and other related life science consulting services to pharmaceutical, biotechnology, and medical device industries. We are GLP, GMP and GCP certified. We also have a team of  project managers who are PMP certified with experienced in clinical trial services and management. Our medical device service management team provide Medical Device Installation, Repairs, Preventive Maintenance, and Qualification. We manage all services to maintain medical devices throughout its lifecycle. TEDMED Engineering’s Equipment Maintenance Management Program (EMMP) is the most effective approach to managing all numerous service contracts. We replace manifold service agreements, and long warranties with one agreement that costs less and is more flexible than traditional contracts. We access equipment service contracts for our clients and end the warranty period to reduce cost.  Our team of engineers are specialized to maintain, repair, and qualify medical device equipment, when taken out of OEM service contract, or without service contract. We also offer a single point of contact for managing service vendor. Our EMMP program delivers coverage that includes the costs associated with parts, labor, travel, emergency repair, and preventative maintenance. Learn more about us at www.tedmedengineering.com

https://lnkd.in/guB7rRmR Clinical Research Trials Training for beginners and advance students Created by Elizabeth Betty Bonsu, Founder and President, TMEP & TMEP Divinity Research Center. www.tedmedengineering.com

https://lnkd.in/gRVKcAaV Clinical Research Trials Training for beginners and advance students. ( Part 1) Created by Elizabeth Betty Bonsu, Founder and President, TMEP & TMEP Divinity Research Center www.tedmedengineering.com

#MedicalDeviceclassification #regulatorysubmissions #fdaregulations

Companies cannot market new drugs, medical devices, or biological products, without providing to the U.S. Food and Drug Administration (FDA) proof that the product is safe. Hence, there are types of Clinical trials conducted to show safety, and efficacy of the product. Regulatory agencies assess the information and data provided by sponsors and investigators, and then decide to approve or reject the marketing application for the product. The International Council for Harmonization (ICH) E6 standards, has been implemented in the U.S., Europe, Japan, and other countries, to aid in compliance with regulatory requests of many of governmental regulatory agencies. ICH E6 R1, and its 2016 addendum R2, relates to conducting clinical trials of drugs, medical device and biologics that abide by Good Clinical Practice (GCP) standards. Many Sponsors and contracted CRO's prefer following ICH GCP guidelines in combination with FDA guidelines to conduct research trials. It is important to note that ICH GCP guidelines are merely a standard in the US and not an enforceable law. Nonetheless, all sponsors require their trials to be conducted in a manner that follows both FDA and ICH GCP standards. GCP standards are broader than FDA guidelines. ICH, 2016 E6 GCP guidelines, Section 5.0 states that the sponsor should create a system to achieve quality in all phases of the clinical trial. The quality management system should use a risk-based method. This was an essential change for trial monitoring, that extends beyond just routine periodic record auditing. For example, the new ICH E6 integrated addendum (R2), requires sponsors to implement a risk-based process that identifies risks in the study. Sponsors are also required to perform a root case analysis, and also CAPA, Corrective Action and Preventative Action when needed. Section 4.9.0 of ICH E6 also requires the investigator to sustain adequate and accurate source documents and trial proceedings including all related notes on each of the site’s trial participants. Paper, or electronic source data must follow ALCOA-C. This means it needs to be attributable, legible, contemporaneous, original, accurate, and complete. Any changes to source data should be traceable, it shouldn’t obscure the original entry, and must explained if needed. ICH E6 Section 5.5.3 further states that the sponsor must confirm that the electronic trial data handling and/or remote electronic trial data systems follow the sponsor’s written requirements for completeness, accuracy, reliability, and are validated. Written requirement should be a written standard operating procedure also know as SOPs. It is the responsibility of the Sponsor's / CRO's to hire a Clinical Research Professionals who are very experienced in other areas to maintain cost. Contact us to not only perform monitoring, and auditing of your study trials, but to also validate all your regulatory quality management electronic data.

Projects are not permanent, its has a start and end date, and it should end with very good results. For projects to be successful, it needs to be well planned, managed, monitored and controlled in order to meet stakeholders expectation and that is our mission. We are devoted to monitoring, and auditing research projects to promote patient safety through utilizing our expertise in all aspect of clinical trials, medical device engineering, project management, and quality data management to ensure that all research we managed are conducted with safety as the number one priority.

Our services includes: Drug and Medical Device development projects. Clinical Trial Auditing and Monitoring. Quality Assurance / Quality Control. Statistical Analysis. Comprehensive US FDA Regulatory and Submission Strategy. Novel Device classification. Identification of Predicate Device for Substantial Equivalence Analysis. Gap Analysis as per US FDA regulation and International standards. Compilation of all sections of 510(k) Technical File in eSTAR format. Investigational New Drug (IND). New marketing applications (NDA). All FDA Submission. Business, Ethical and Legal aspects of clinical research. Investigational product manufacturing process validation. Computer & Data Validation. Equipment Validation (IQOQPQ). Facility Validation. Protocol design and SOP development. FDA Regulatory guidelines and many more...