Medical Device Solutions

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At Clinetra Solutions, we go beyond being just a regulatory partner — we act as a strategic ally for medical device companies navigating the complex, ever-changing global landscape. Whether you are a start-up developing your first device or an established manufacturer managing a diverse portfolio, our mission is to accelerate your journey from concept to commercialization while ensuring the highest standards of quality and safety.

We provide end-to-end solutions across the entire device lifecycle, covering earlystage product development, clinical evaluations, regulatory submissions, and postmarket surveillance. Our multidisciplinary team of experts combines regulatory intelligence, scientific know-how, and technology-driven tools to reduce uncertainty, shorten timelines, and minimize compliance risks.

At every step, we ensure your devices are not only innovative in design and function, but also safe for patients, compliant with global regulations, and ready to succeed in international markets. With Clinetra by your side, you gain the confidence that your innovation can withstand scrutiny, meet regulatory expectations, and truly make a difference in patient care.

The global medical device market is projected to surpass USD 650 billion by 2030, driven by innovation, stricter regulations, and a rising demand for safer, smarter healthcare solutions

Our Expertise in Medical Devices

1. Regulatory Strategy & Submissions We simplify regulatory pathways with tailored strategies that accelerate approvals. Our team supports submissions across regions, including FDA, EMA, MHRA, TGA, Health Canada, and CE marking under EU MDR.

2. Technical Documentation Strong documentation is the backbone of compliance. We prepare, review, and update:

• Technical Files & Design Dossiers

• Clinical Evaluation Reports (CERs)

• Risk Management & Usability Engineering Files

• Labelling & IFU Compliance.

3. Clinical Evaluation & Investigations We conduct robust literature-based and clinical investigation-driven CERs in compliance with MDR Annex XIV. Our experts provide strategies for Post-Market Clinical Follow-Up (PMCF) to strengthen clinical evidence.

4. Post-Market Surveillance & Vigilance Medical device compliance doesn’t end with approval. We help you monitor safety, gather real-world evidence, and act proactively through:

✪ PMS Plans & Reports (PMCF/PMPF)

✪ Vigilance Case Management & Incident Reporting

✪ Risk-Benefit Assessment Updates

5. Gap Analysis & Audit Readiness Our consultants perform compliance gap assessments to ensure your files, processes, and teams are audit-ready, minimizing risk in inspections and regulatory reviews.

Why Partner with Clinetra?

✔ Global Regulatory Expertise – In-depth knowledge of international frameworks (EU MDR, IVDR, FDA 21 CFR, ISO 13485).
✔ Faster Market Entry – Strategic submissions that avoid delays and reduce regulatory hurdles.
✔ Lifecycle Support – From concept to post-market, we support every stage of your device.
✔ Dedicated Experts – Specialists in clinical, regulatory, and vigilance activities.
✔ Audit-Ready Assurance – Compliant documentation and processes built to withstand scrutiny.

Industries We Support
❄︎ Medical Device Manufacturers
❄︎ In-Vitro Diagnostic (IVD) Companies
❄︎ Start-Ups Scaling to Global Markets
❄︎ CROs & Regulatory Partners
Moving Devices Safely from Innovation to Market

With Clinetra Solutions, your medical devices are supported by a partner who understands both the complexities of compliance and the importance of patient safety. From design to distribution, we provide the guidance, strategy, and expertise to bring your innovation closer to those who need it most.

Get in touch with our Medical Device Experts today

Clinetra solutions, 3rd floor, Saptagiri complex, Pillar number-A743, Backside KPHB bus stop, Kphb Phase 1, Hyderabad, Telangana 500072

Designed & Developed by B G Krishna, +91 9494163200