Legal Process

FirsTeckBio offers professional IVDR and FDA compliance consulting services, ensuring your conformity and successful market entry in the regulatory landscape of In Vitro Diagnostic Devices in Europe and the USA. The European Union's In Vitro Diagnostic Medical Device Regulation (2017/746 IVDR) came into effect on May 26, 2022. Our IVD consulting division provides accurate information and abundant resources, including technical file reviews, Notified Body consultations, and more, to assist IVD manufacturers in formulating compliance strategies.

海外临床
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Compliance Consulting - CE Marking
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Post-Market Surveillance Services
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UDI EUDAMED Registration
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EU Representative
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Quality Management System, QMS Consulting
Performance Analysis Studies

01. GAP Assessment: Identify discrepancies between expected and actual performance using existing data.
02. Study Design: Define objectives, select methods, and set up conditions to address identified gaps.
03. Study Execution: Collect comprehensive data through experiments or real-world usage.
04. Report Compilation: Analyze findings, write a detailed report summarizing objectives, methods, and conclusions, and provide recommendations.

We conduct product development and validation studies in EU labs, including new reagent tests and batch verifications. We also compare products against top standards for marketing-driven performance validation, ensuring competitive edge and quality enhancement.

Scientific Validity Studies

01. Literature Review: Analyze relevant scientific literature to build a foundational knowledge base.
02. Expert Consultation: Seek insights from field experts and professors for validation and depth.
03. Data Integration: Merge performance and clinical data to evaluate overall scientific validity.


Following ISO 13485:2016, Commission Implementing Regulation (EU) 2022/1107 (Common Specifications), WHO-Technical Specifications Series (TSS), FDA (510K), TGA, GLP, Clinical & Laboratory Standards Institute: CLSI Guidelines