Navigate ICMED 13485 Plus with Confidence

Understanding ICMED 13485 Plus Scheme

Highly Cost-Effective Compared to CE or US FDA

Ensures Patient Safety through Product Level Testing

Assures Buyers of Rigorous Quality and Safety Standards

Competitive Edge in Indian Healthcare Market

Build Trust in Indian-Made Devices

Recognized by Indian regulatory authorities

Streamlined certification process compared to international standards

End-to-End quality assurance scheme for the medical devices sector in India

Key Benefits

ICMED 13485 Plus is more than a certificate — it's a commitment to quality, safety, and trust in the Indian medical device ecosystem.

We help you build a system that ensures ongoing compliance, safety, and market access. Whether you’re a new entrant, scaling manufacturer, or seeking recognition for Indian buyers, we set the stage for successful certification under this trusted national scheme.

Our ICMED 13485 Plus Solutions

We offer structured, hands-on support across every stage of the certification journey.

Gap Assessment & Readiness Check

We evaluate your current QMS, product documentation, and testing status against ICMED 13485 Plus requirements to identify gaps and build a tailored action plan

Technical Documentation Support

We help you prepare or upgrade your QMS documents, product dossiers, risk files, IFUs, and test plans—aligned with ISO 13485 and ICMED 13485 additional requirements.

We guide implementation of compliant procedures across production, QC, traceability, and device history records—ensuring audit readiness.

On-Site Process Alignment

We assist with identifying suitable NABL labs, coordinating type testing, and compiling results for submission to the certification body.

Type Testing & Lab Coordination

Certification Body Liaison & Audit Support

We coordinate with QCI-accredited Certification Bodies, handle application formalities, and provide hands-on support during Stage 1 and Stage 2 audits.

Post-Certification Surveillance & Improvement

We help you prepare for surveillance audits, CAPA management, and maintain ongoing compliance as per ICMED’s 3-year certification cycle.

Key Deliverables

• Complete Technical Documentation including labelling requirement

• Device Master File (DMF)

• Clinical Evaluation Report (CER)

• Risk Management File (RMF)

• PMS Plan

• Quality Management System Documentation Support as per ICMED

• Essential Safety Requirements (ESR) Checklist

• Declaration of Conformity (DoC)

End-to-end Compliance Support

Audit-Ready Technical Documentation

Notified Body Approval Support

Post-market Surveillance setup

Ongoing Regulatory Support

Who We Help?

First-Time Applicants

Manufacturers Without In-House Regulatory Teams

Whether you're a Startup, SME, or an established manufacturer, we tailor our support to meet your specific product, process, and team needs.

OEMs & Contract Manufacturers

Companies applying for government tenders or GEM portal listings

Startups & Innovation-Driven Enterprises

Established Manufacturers Seeking Market Expansion

Ready to get India's first product level certification?

Let’s help you achieve it with ease.

Why Choose VIDHA?

Expertise You Can Trust

Hands-on experience, backed by a strong understanding of global and Indian regulatory frameworks.

Personalized Solutions

We tailor every document, process, and support plan to your specific device class, regulatory pathway, and business goals.

Reliable & Confidential Support

We prioritize confidentiality, integrity, and compliance — ensuring your data and submissions are handled with care and professionalism.

Our services are focused, efficient, and aligned with your timelines and budgets.

Timely & Cost-Effective Delivery