Compliance Made Simple. Innovation Made Possible.
We help startups and enterprises turn compliance from a barrier into a growth engine.
We help startups and enterprises turn compliance from a barrier into a growth engine.
At Qualentra Global, we believe that regulatory compliance should fuel innovation — not hinder it. We are a global MedTech compliance partner focused on helping startups, SMEs, and innovation-driven institutions bring life-changing products to market with speed, precision, and full regulatory confidence.
Experts
Countries Support
years of Combined team Experience
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Innovations Handled
we simplify the complex. From product ideation to post-market support, we provide end-to-end regulatory, quality, and innovation services tailored for the MedTech ecosystem. Our multi-disciplinary team helps startups, MSMEs, institutions, and global firms accelerate market entry with confidence.
We guide you through the entire regulatory lifecycle from early classification to global approvals.
Build robust, audit-ready Quality Management Systems aligned with ISO 13485 and regional standards.
We ensure your innovation aligns with regulatory expectations from day one.
Scientific support and coordination for ISO-compliant testing.
Upskill your team and ecosystem with regulatory and quality training tailored for real-world challenges.
We manage the critical details to ensure your product is shelf-ready and globally acceptable.
We create powerful digital assets that communicate, train, and streamline your compliance journey.
More than compliance consultants — we're your strategic MedTech partners, bringing clarity, structure, and speed from prototype to global launch.
We understand the unique challenges early-stage companies face. Our approach is agile, practical, and designed to fit your growth trajectory — not overwhelm it.
We support compliance across India, the US, EU, Australia, ASEAN, and more. Our deep understanding of international pathways gets you there faster — and safer.
From R&D to regulatory approvals, from QMS to post-market support — we cover the entire product journey. You don’t need multiple vendors; we’re your single partner.
We offer more than just documents — we bring your compliance to life through AR/VR tools, e-learning modules, dashboards, and animated regulatory explainers.
we follow a proven, streamlined process to get your innovation from idea to market — with full compliance.
We start with a free consultation to understand your product, goals, and compliance needs. Then we chart a custom roadmap aligned with regulatory milestones.
We help you build or align technical files, QMS systems, and product risk assessments — all tailored to your region and device type.
From training to eQMS setup, clinical evaluations to testing coordination — we execute your compliance framework step by step, with full support.
We prepare and manage regulatory submissions, including interactions with CDSCO, CE bodies, FDA, or other authorities — ensuring timely, audit-ready results.
Once approved, we help you stay compliant — with surveillance, labeling updates, vigilance systems, and global scale-up planning.
Our clients don’t just meet regulatory requirements — they gain a strategic edge. Here’s how we help you turn compliance into a competitive advantage
Have questions about our services? Our 'Frequently Asked Questions' section.
Yes, most Class B/C/D devices require a QMS audit or certification for approval in CDSCO, EU, and FDA pathways.
Absolutely. We develop parallel pathways to optimize approval timelines and documentation reuse.
Ideally during design or feasibility stage—compliance starts with the first design decision.