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Technology Readiness Levels (TRL)* provide a metric that may help to describe the progression of a technology in its development. Several groups have adopted the TRL system for use regarding life science technologies, including the Department of Health and Human Services. TRLs are based on a scale from 1 to 9 with 9 being the most mature technology. The TRLs enables consistent, uniform discussions of technical maturity across different types of technologies. The TRL format was originally developed by NASA and the Department of Defense.
*adapted from the National Institutes of Health (NIH)
REVIEW OF SCIENTIFIC KNOWLEDGE BASEActive review and analysis of scientific literature. Identify rationale for a potential new product. | |
DEVELOPMENT OF HYPOTHESES AND EXPERIMENTAL DESIGNSScreen potential compounds; initial experimental designs for technology solution; Initial intellectual property search for patentability. | |
IDENTIFICATION AND CHARACTERIZATION OF PRELIMINARY PRODUCT; PROOF-OF-PRINCIPLESelect compounds to advance to lead, begin non-GLP testing program; Explore prototypes, critical design features and components; demonstrate in vitro efficacy; file IP. | |
OPTIMIZATION AND DEMONSTRATION OF ACTIVITY AND EFFICACYIdentify markers, assays, and endpoints for nonclinical and clinical studies, define formulation and product profile, select final pre-clinical lead compound; Initiate Design Control activities, establish Design and Development Plan, develop regulatory strategy. | |
ADVANCED CHARACTERIZATION OF PRODUCT AND INITIATION OF MANUFACTURINGExplore potential manufacturing options as well as manufacturability and sustainability of product design, including third-party partners and seek regulatory guidance, if appropriate. Begin studies supporting regulatory requirements. | |
REGULATED PRODUCTION, REGULATORY SUBMISSION, AND CLINICAL DATAPrepare and submit regulatory filings, if appropriate. Begin P1 safety for NCE/NBE or P2 on repurposed compound; Manufacture product compliant with quality protocols or GMP depending on device classification. | |
SCALE-UP, INITIATION OF GMP PROCESS VALIDATION, AND PHASE 2 CLINICAL TRIAL(S)Scale-up manufacturing, process validation; P2 efficacy program; post-P2 FDA meeting; device scale-up, device and diagnostic outcomes validated, regulatory submissions for marketing clearance; supply chains finalized. | |
COMPLETION OF GMP VALIDATION AND CONSISTENCY LOT MANUFACTURING, CLINICAL TRIALS PH3, AND FDA APPROVAL OR LICENSURERelevant regulatory submissions to request marketing. | |
MARKET LAUNCH AND POST-MARKET SURVEILLANCESupply chain contracts active, sales and distribution forces active, post-marketing studies active (as required). |
Section Subtitle
V12 114190 0002 REV. 00
ENGLISH
| No. | V12 114190 0002 Rev. 00 |
| Type | Directive Certificates for Systems |
| Type Name | Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices, Annex IX Chapters I and III |
| Certification Body | TÜV SÜD Product Service GmbH, Ridlerstr. 65, 80339 Munich, Germany |
| Holder of Certificate | Ustar Biotechnologies (Hangzhou) Ltd. Bldg 1,2&4, 611 Dongguan Road Binjiang District 310053 Hangzhou, Zhejiang Province;SRN Manufacturer - CN-MF-000014615 People's Republic of China |
| Valid from | 2023-07-11 |
| Status | Valid |
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Dr. Sarah Lee, Chief Medical Officer
Founder and chief visionary, Tony is the driving force behind the company. He loves to keep his hands full by participating in the development of the software, marketing, and customer experience strategies.
Mich Stark, COO
Mich loves taking on challenges. With his multi-year experience as Commercial Director in the software industry, Mich has helped the company to get where it is today. Mich is among the best minds.
Aline Turner, CTO
Aline is one of the iconic people in life who can say they love what they do. She mentors 100+ in-house developers and looks after the community of thousands of developers.
John Smith, CFO
Iris, with her international experience, helps us easily understand the numbers and improves them. She is determined to drive success and delivers her professional acumen to bring the company to the next level.