Risk Management (ISO 14971)

✅ Early identification of hazards

✅ Effective risk control strategies

✅ Justified and documented residual risks

✅ Alignment with design, usability, and post-market feedback

Why Risk Management Matters?

❌ Patient Harm

❌ Regulatory non-compliance

❌ Product recalls or market suspension

❌ Loss of trust due to impact on product safety

Explore our Services

In medical devices, risk is inevitable — but must be controlled. Managing those risks isn’t optional — it’s Mandatory.

A strong Risk Management Framework ensures:

Without a structured risk management process:

Proactive Identification. Thorough Evaluation. Effective Control.

Therapeutic Equipment

We assist you in creating a system that goes beyond checklists — embedding risk thinking in every decision related to design, manufacturing, post-market surveillance, and clinical use.

Diagnostic Devices

Software-based System

Whether you are developing:

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What We Do?

We offer full-scope risk management tailored to your device type, development stage, and regulatory target

Risk Management Policy & Gap Assessment

Evaluate current Risk Management File (RMF) against ISO 14971
Identify documentation and process gaps
Define or refine organizational risk policy and risk acceptability criteria.
Build a tailored compliance action plan

Risk Management Plan (RMP)

Define scope, responsibilities, and risk acceptability criteria.
Set methods for risk evaluation and benefit–risk determination.
Establish periodic review schedules and integrate production/post-market data.

Identify potential hazards and hazardous situations across the device lifecycle
Identify reasonably foreseeable misuse
Estimate risk levels using defined severity and probability criteria
Link identified risks to control measures and verification evidence

Hazard Identification & Risk Analysis

Select appropriate control measures (design, protective, information-based)
Evaluate control effectiveness and justify residual risk acceptability
Align with usability engineering, product labeling, and regulatory expectations

Risk Control & Residual Risk Evaluation

Risk Management File (RMF) Preparation

Build complete, ISO-compliant RMFs with traceability from hazard to control evidence
Link RMF to Design inputs, Clinical Evaluation, PMS/PMCF, and QMS documentation
Integrate ongoing production and post-production data into RMF updates

Final Risk Review & Benefit-Risk Analysis

Confirm completion of all planned risk management activities.
Document benefit–risk determinations for any unacceptable residual risks.
Provide audit-ready documentation aligned with regulatory expectations

Key Deliverables

Risk Management Plan (RMP)
Hazard Identification and Risk Analysis Matrix
Risk Control & Residual Risk Summary
Benefit-Risk Analysis
Risk Management Report (RMR)
Complete Risk Management File (RMF)

End-to-end Compliance Support

Audit-Ready Technical Documentation

Notified Body Approval Support

Integration with Clinical & PMS Data

Ongoing Regulatory Support

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Ready for a compliant, audit-ready Risk Management?

Let’s help you achieve it with ease.

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Our Workflow

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Understand Your Product & Goals

Map the Regulatory Pathway

Support You Beyond Approval

Execute with Precision

Communicate Transparently

Maintain Ethics & Confidentiality

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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

What types of risks are covered in medical device risk management?

Risk management addresses clinical risks (impact on patient safety and performance), technical risks (malfunctions, failures), and usability risks (human factors, user interface). The goal is to ensure device safety and performance throughout its lifecycle.

When should Risk Management start?

Risk management begins during product concept and continues through design, manufacturing, market release, and post-market surveillance. It’s not a one-time activity but a continuous process updated with new data from production, PMS, and vigilance reports.

Do you help with audit responses or reviewer comments?

Yes. If you've received feedback during an audit or submission (e.g., from Notified Bodies, CDSCO, or QCI), we can assess the gaps in your current risk documentation and support you with corrective updates and justifications.

FAQs

How often should I update my risk management documentation?

Updates should occur whenever there are significant design changes, new regulatory requirements, safety alerts, or post-market findings that affect the device’s risk profile. Many manufacturers also align updates with their CER or PMS review cycles.

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