Medical Device Consultancy from Concept to Commercialization
From low-risk consumables to life-sustaining devices, Suchigo Consulting supports project consultancy across every medical device classification.
Medical devices in India are grouped into four risk-based classes — A, B, C, and D — under the country's Medical Device Rules. The classification a device falls under shapes the regulatory pathway, manufacturing controls, and documentation a project needs to account for from the outset. As your medical device consultant, Suchigo Consulting supports manufacturing project consultancy across all four classes.
| Class | Risk level | What it typically covers |
|---|---|---|
| Class A | Low risk | Non-invasive devices with minimal patient contact. Regulatory requirements are comparatively light, but manufacturing setup still needs to reflect basic quality and documentation standards. |
| Class B | Low-moderate risk | Devices contacting mucous membranes or used short-term. Manufacturing and regulatory planning need to account for moderate compliance requirements at this stage. |
| Class C | Moderate-high risk | Invasive devices entering the body or internal fluid pathways. This category typically calls for closer regulatory scrutiny and more rigorous manufacturing controls. |
| Class D | High risk | Devices contacting the cardiovascular or central nervous system, or sustaining life. This is the most heavily regulated category, and manufacturing project planning needs to reflect that from the earliest stage. |
How we support each classification
Regulatory expectations rise sharply as device risk increases, and manufacturing project planning needs to reflect that from the earliest stage — a Class A production setup looks very different from one intended for Class D devices. Suchigo Consulting's project consultancy — covering facility planning, statutory approvals, and manufacturing setup — is shaped around the classification your device falls under, so the project is built to the right regulatory standard from day one.
Frequently Asked Questions
Find answers to common questions about our pharma and medical device consultancy services.
Suchigo Consulting provides medical device consultancy covering product classification, regulatory guidance, facility planning, cleanroom design, equipment selection, process validation and manufacturing setup. We support medical device manufacturers from concept development through production readiness and commercialization.
Medical device classification determines the regulatory pathway, manufacturing controls, quality systems and documentation required for your facility. Suchigo Consulting helps align project planning and manufacturing setup with the applicable Class A, B, C or D requirements from the outset.
Yes. Suchigo Consulting supports new Greenfield medical device manufacturing facilities as well as Brownfield expansion, upgrading and modernisation projects. Our consultancy covers facility planning, regulatory alignment, engineering coordination, equipment planning and commercial production readiness.
Yes. Suchigo Consulting provides guidance on ISO 13485 quality management system requirements for medical device manufacturing facilities. Our consultancy helps align facility design, manufacturing processes, validation and quality systems with applicable medical device regulatory and compliance expectations.
Share your medical device project requirement with Suchigo Consulting, including the product, classification if known, proposed location and current project stage. We will discuss your objectives and guide you through the appropriate regulatory, facility planning, manufacturing setup and next steps.
Share your requirement, and we'll help identify what your device's classification means for your manufacturing project.
Share Your Requirement