Why a Robust QMS is Essential?

Mandatory for Regulatory Compliance

Prepares You for Audits & Inspections

Customer Confidence & Quality Culture

Reduces Risk & Variability

Key Benefits

A QMS is not limited to a specific device or product class — it is a company-wide system. It governs how your organization plans, controls, documents, and improves quality across design, production, procurement, servicing, and post-market activities.

Which QMS Standard is Right for You?

Whether you’re targeting exports, government tenders, or internal process improvement — the right QMS standard makes all the difference. Here's a quick side-by-side breakdown to help you decide based on your product, market, and certification goals.

How We Can Help?

End-to-end support for QMS design, implementation, compliance, and continual improvement.

QMS Implementation & Documentation

• Help you build your QMS from scratch

• Gap analysis and reviewing your existing QMS

• Quality Manual, SOPs, and Work Instructions

• Process mapping and risk-based controls

• Document control, record formats, templates

Certification Planning & Audit Preparation

• Selection of appropriate QMS standard and certification body

• Creation of certification roadmap and timeline

• Alignment with ISO 13485 / ICMED 13485 / ISO 9001 requirements

• Review of readiness documents (MRs, audit plans, checklists, mandatory procedures)

• Internal audit planning and execution

• Corrective & preventive action (CAPA) tracking

• Closure of non-conformities and documentation updates

• Mock audits for ISO/ICMED readiness

Internal Audit & Non-Conformity Closure

QMS Enhancement & Continual Improvement Support

• Periodic document review and update

• Support for management review preparation

• Improving CAPA closure effectiveness

• Risk-based revision of processes as needed

Key Deliverables

• Quality Manual, Quality Policy & Quality Objectives

• Standard Operating Procedures (SOPs) & Work Instructions

• Document Control Formats & Record Templates

• Process Maps & Risk-Based Controls

• Risk Management File (if applicable)

• QMS Documentation Support (as per IMDR 2017 – Fifth Schedule)

• Master List of Documents and Records

• Design and Development Documentation (if applicable)

• Internal Audit & Management Review Records

End-to-end Implementation Support

Audit-Ready QMS Documentation

Certification Body Audit Support

Post-market Surveillance setup

Ongoing Regulatory Support

Who We Help?

First-Time Applicants - building QMS from scratch

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.

Companies Transitioning from ISO 9001 to ISO 13485

OEMs & Contract Manufacturers

Companies applying for government tenders or GEM portal listings

Startups & Innovation-Driven Enterprises

Established Manufacturers Seeking Market Expansion

Exporters & Importers Handling CDSCO or Foreign Market Approvals

Ready to Implement a strong Quality Management System?

Let’s build a system that works for your team — not just your certificate.

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

Frequently asked questions

FAQs