TEDMED Engineering and Projects.

Our services Highlights:

                       

 CLINICAL TRIAL MANAGEMENT

We are an established Clinical Research and Development consultants (CRDO).  We are Clinical Research Professional with Specialization in Project Management and over 16 years of experience with extensive education in Project Management, Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices.
We provide drug and medical device research development lifecycle management from discovery and development, we offer GLP practices, Laboratory Project Management, Regulatory Submissions, Clinical Trials Management, Site Selection, Auditing and Monitoring of Clinical Research sites and GMP Sites.
We provide services to Startup's, Vendors, CRO and Sponsors in Pharma, Biotech, CDMO, CMO, CRAMS etc.

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.                                          We offer:

Drug and Medical Device development projects.
Clinical Trial Auditing and Monitoring.
Quality Assurance / Quality Control.

Medical Device PM, Calibration and Qualification.
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) submission.
New Drug Applications (NDA) submission
All other FDA Submissions. 
Investigational product manufacturing process validation.
Computer & Data Validation.
Equipment Validation (IQOQPQ).
Facility Validation.
Protocol design and SOP development.
FDA Regulatory guidelines and many more.........

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MEDICAL DEVICE MANAGEMENT

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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. 

Ensuring regulatory compliance of your medical devices requires expert Engineers. TedMed Engineering compliance tracker provides you with an innovative and empowering solution.

We help you ensure compliance throughout your medical devices development cycle.

We help you access comprehensive, up-to-date standards and regulatory information from a trusted source.

We help you stay informed of any changes to standards and ensure you are the first to know when there is any recall that requires immediate correction.

We outsource parts for equipment that is no longer supported by the manufacturer.

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.