Industries We Serve

We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.

Rescisco Global Regulatory Consultants > About Us > Industries We Serve

One Firm. Every Corner of Healthcare.

Healthcare regulation is not one-size-fits-all. A cardiac implant and a rapid antigen test have nothing in common — except that both demand precise, uncompromising regulatory management. We bring specialised expertise to every sector we serve.

🩺

Medical Devices

Class A–D devices across cardiology, orthopaedics, ophthalmology, surgical instruments, wound care, dental, respiratory, and more. CDSCO to FDA to EU MDR pathways.

🧫

In-Vitro Diagnostics (IVDs)

Immunoassays, molecular diagnostics, point-of-care tests, biochemistry analysers, and laboratory instruments. EU IVDR, CDSCO IVD rules, and FDA 510(k) for diagnostics.

💊

Pharmaceuticals

Drug-device combination products, pharmaceutical manufacturing facility compliance, GMP gap analysis, and CDSCO/USFDA pharmaceutical licensing support.

💻

Software as Medical Devices

AI/ML-based diagnostics, clinical decision support, mobile health apps, and hospital information systems. IEC 62304, IMDRF SaMD frameworks, and DISHA-aligned guidance.

⚡

Active Electromechanical Devices

Imaging systems, infusion pumps, monitoring equipment, electrosurgical units, physiotherapy devices. IEC 60601 compliance, EMC testing, and electrical safety documentation.

🔬

Nutraceuticals & Cosmetics

FSSAI compliance, cosmetic ingredient safety assessments, borderline product classification, and regulatory strategy for functional foods and wellness products.

🏥

Hospitals & Diagnostic Centres

NABH documentation support, NABL accreditation for labs (ISO 15189), quality management system design for healthcare service providers.

🧬

Contract Research & CROs

Clinical investigation regulatory support, ethics committee submissions, informed consent frameworks, and ICH GCP compliance for clinical research organisations.

"India's medical device market is one of the fastest-growing in Asia. But growth without compliance is growth with an expiry date. We help manufacturers build reputations that last."

— Rescisco Global, Market Perspective