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In Vitro Diagnostic (IVD) Services by Medivdpharma (MIP)
Medivdpharma (MIP) provides end-to-end support for the development, testing, and regulatory compliance of In Vitro Diagnostic (IVD) devices. Our services ensure that IVD products—ranging from rapid tests to complex laboratory systems—meet stringent quality, safety, and performance standards required for global markets.
What Are IVD Devices?
In Vitro Diagnostic (IVD) devices are tests used to analyze human samples (e.g., blood, urine, tissue) outside the body. They play a critical role in:
- Diagnosing diseases (e.g., infections, cancer, genetic disorders)
- Monitoring health (e.g., blood glucose levels, cholesterol)
- Guiding treatment decisions (e.g., companion diagnostics)
Examples of IVDs:
- Pregnancy test kits
- Blood glucose monitors
- HIV and infectious disease test kits
- Cancer screening assays
- COVID-19 rapid tests
Note: IVDs include reagents, calibrators, and specialized apparatus but exclude general lab equipment.
Comprehensive Solutions, Tailored for You
Regulatory Compliance & Submissions
- IVDR (EU) & MHRA (UK) Compliance: Full support for regulatory strategy, documentation, and submissions.
- Device Registration: Assistance with registering IVDs in target markets.
- Technical File Compilation: Preparation of compliant technical documentation for Notified Body review.
- Analytical Performance Studies: Sensitivity, specificity, precision, and accuracy testing.
- Clinical Performance Studies: Design and execution of trials to validate clinical utility.
- Data for Submissions: Generating robust evidence for regulatory approvals.
- Reagent and Device Stability: Assessing shelf-life and storage conditions.
- Batch Consistency: Ensuring manufacturing consistency and product reliability.
- Real-Time & Accelerated Stability Studies: ICH-compliant testing protocols.
- Biocompatibility Testing: Evaluating materials for safety.
- Leachables & Extractables Studies: Identifying potential contaminants.
- Raw Material Qualification: Ensuring component quality and traceability.
Biomarker & Assay Development
- Assay Optimization: Developing and validating novel assays for biomarkers.
- Prototyping Support: Translating concepts into functional diagnostic tests.
- Technical Transfer: Scaling assays from development to manufacturing.
- Vigilance Reporting: Managing incident reports and adverse events.
- Periodic Safety Updates: Preparing PSURs and trend analyses.
- Field Corrective Actions: Supporting recalls or design updates if issues arise.
Why Partner with MIP
for IVD Services?
Trust MIP to navigate the complexities of IVD development and regulatory compliance, ensuring your
diagnostics reach patients safely and efficiently.
diagnostics reach patients safely and efficiently.
Expertise Across Regulations
Deep knowledge of IVDR, FDA, MHRA, and other global frameworks.
Speed to Market
Streamlined processes to accelerate regulatory approvals and commercialization.
End-to-End Support
From concept to post-market surveillance.
Quality-Driven Approach
Rigorous testing and validation to ensure product safety and efficacy.
Our case study
Explore our outstanding client projects
Empower enterprise
Empower enterprise
In today's dynamic business environment, the key to success lies strategics our planning and operational business.
Prime strategy partners
Prime strategy partners
In today's dynamic business environment, the key to success lies strategics our planning and operational business.
Innovate consultancy
Innovate consultancy
In today's dynamic business environment, the key to success lies strategics our planning and operational business.
Business strategies
Business strategies
Conduct regular market research to stay in tune with your audience’s needs, behaviors, and trends. This helps you deliver better products, services, and customer experiences.
Strat edge solutions
Strat edge solutions
Conduct regular market research to stay in tune with your audience’s needs, behaviors, and trends. This helps you deliver better products, services, and customer experiences.
Clients feedback
Our clients testimonials
Their thorough market analysis and customized strategies helped us streamline our operations and improve our overall efficiency. We saw a significant increase in our bottom line and were able to make data-driven decisions that positively impacted our business. The consultants were not just advisors in our success
Our experience with Solvior has been nothing short of exceptional. From day one, their team demonstrated a deep understanding of our industry and quickly identified key areas for improvement. Their recommendations were not only innovative but also practical, leading to a substantial operational efficiency.
Our experience with Solvior has been nothing short of exceptional. From day one, their team demonstrated a deep understanding of our industry and quickly identified key areas for improvement. Their recommendations were not only innovative but also practical, leading to a substantial operational efficiency.
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