SciNexis Global Research Pvt Ltd provides end‑to‑end Quality Management System (QMS) documentation and implementation support tailored for medical device and in vitro diagnostics (IVD) organizations. Our QMS frameworks are designed to be audit‑ready, scalable, and aligned with current global regulatory expectations.

What we offer

• Design and implementation of QMS frameworks harmonized with ISO 13485, ISO 9001, EU MDR/IVDR, and US FDA Quality System Regulation (QSR).
• Development, review, and optimization of quality documentation, including quality manuals, SOPs, work instructions, templates, and records.
• Support for risk‑based processes such as design control, change control, CAPA, nonconformance management, complaint handling, supplier qualification, and internal audits.

Benefits for medical device and IVD companies

• Ensures product safety, traceability, and consistent quality across the product lifecycle, from design and development to post‑market surveillance.
• Reduces regulatory and compliance risk by embedding clear, practical procedures that meet international and Indian regulatory requirements.
• Streamlines operations by standardizing workflows, eliminating redundant activities, and integrating quality practices into day‑to‑day business processes.

How SciNexis works with clients

• Collaborative engagement with your cross‑functional teams (R&D, QA/RA, production, regulatory, and management) to map current processes and gaps.
• Tailor‑made QMS roadmaps for startups, growing firms, and established manufacturers, balancing robust compliance with practical implementation.
• Ongoing support for QMS maintenance: internal audit programs, training, continuous improvement initiatives, and inspection/audit readiness.

For more details, reach out to: contact@scinexis.org or call at: +91-8790862453