MedTech Conference 2022 | Techsol Life Sciences

Thank You For Connecting With Us

We are delighted to meet you at the MedTech Event held at Boston this year. As a tech-enabled scientific process organization (TSPO), we specialize in providing modern eClinical technology combined with our value-focused CRO services for clinical development and post-marketing surveillance. We welcome you to meet Dr. Sanket and Satya Sagi at our booth to have a quick conversation about your prioirities and how we can align ourselves to help you.

Tell Us About Your Business Needs

    Regulatory Affairs

    Product RegistrationImport / ExportInvestigational Device Exemption (IDE) SubmissionsUSFDA 510 (k) submissions
    De-novo 510 (k) submissionsPMA SubmissionsManufacturing LicenseLoan Manufacturing License Approvals Support

    Clinical Research

    Feasibility studiesPilot studiesPASS (Post Authorization Safety Follow up) studiesRegistry StudiesPatient Surveys
    PMCF StudiesPMPF (Post Marketing Performance Follow up) for IVDsReal World Evidence StudiesRWD studies

    EU MDR / IVDR Consulting

    Overall EU MDR/IVDR compliance strategyEU-MDR and IVDR Gap analysisNotified Bodies Query responsesLabeling review and updatesTech file remediation Support
    CER writingPMS Plans and ReportsEU UDI implementationEU-MDR and IVDR Consulting Support

    MedTech Medical Writing

    CER (Clinical Evaluation Report) WritingLiterature review summaries on Analytes (IVDs)Performance Evaluation Reports (PER)PMCF plans and reports for Class IIa, IIb, III devicesDevice Vigilance & PSUR writing
    Biocompatibility ReportsToxicology ReportsAudits and QMS Services (ISO13485:2016)Analytical Performance Reports for IVDsEU PMS FSCA ReportingSSCP (Summary for Safety and Clinical Performance)

    What Best Describes You

    Large Pharma & BiotechMid-Size Pharma & BiotechGenericEmerging BiopharmaMedical TechConsultant
    Educational InstitutionTech SolutionsConsumer Health and GoodsPrivate EquityOthers

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    Our Latest Insights

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    Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials

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    Best Practices for Signal Management in Pharmacovigilance

    Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]