Clinical Evaluation & Post Market Support (CER & PMS)

✅ Smooth regulatory approvals

✅ Continuous market presence

✅ Strong clinical and customer confidence

✅ Faster expansion into new markets

Why CER and PMS Matters?

❌ Regulatory non-compliance and penalties

❌ Product recalls or market suspension

❌ Loss of clinical trust and reputation

❌ Missed global market opportunities

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What is a Clinical Evaluation Report (CER)?

Literature reviews and clinical data appraisal

Equivalence justification (if applicable)

PMS, PMCF, and vigilance data integration

Safety and performance analysis

Explore our CER Support

A CER is a structured document demonstrating the clinical safety and performance of a medical device based on existing clinical data.

We help you build:

Benefit-Risk Conclusions

CE Marking

ICMED 13485 Plus Compliance

Ongoing lifecycle documentation

A CER file is required:

What is Post Market Surveillance (PMS)?

PMS Plans & Reports (as per MDR/IMDR)

Trend analysis & signal detection

Integration with CER & Risk Management files

Complaint & vigilance tracking

Explore our PMS Support

PMS keeps your device safe after it hits the market — and keeps you compliant.

We support you with:

PMCF strategy (if applicable)

QMS & CE compliance

ICMED 13485 Plus Compliance

Clinical Evaluation & Risk Management

PMS is essential for :

Our CER Solutions

We provide complete support for Clinical Evaluation — from planning to regulatory updates

Clinical Evaluation Plan (CEP)

We create compliant CEPs covering methodology, objectives, and literature strategy.

Literature Search & Data Appraisal

We perform and document structured literature searches and data quality assessments

Technical, clinical, and biological comparisons, along with access justification

Equivalence Assessment

We prepare complete, compliant CERs linked to PMS and Risk Management

CER Writing & Compilation

CER Gap Assessment

We review CERs, find compliance gaps, and recommend corrective actions

CER Updates & Lifecycle Support

We update CERs to reflect PMS findings, device changes, and regulatory feedback

Our PMS Support

We provide complete Post Market Surveillance solutions tailored to your target regulations — whether EU MDR, IMDR 2017, ISO 13485, or other market requirements.

PMS Plan

Development of compliant PMS plans, including PMCF plans where required.

Data Collection & Analysis

Gathering and evaluating post-market data to identify trends, risks, and improvement opportunities.

Preparation of PMS reports, PSURs, or other required submissions based on applicable regulations.

Regulatory Reporting

Linking PMS outcomes to CER, Risk Management, CAPA, and IFU updates.

Integration with QMS

Regulatory Update Support

Updating PMS documentation to reflect new data, regulatory changes, or audit feedback.

Key Deliverables

Clinical Evaluation Plan (CEP)
Literature Search & Appraisal Documentation
Demonstration of Equivalence, if applicable
Clinical Evaluation Report (CER)
PMS/ Post Market Clinical Follow-up (PMCF) Plan
PMCF Report, if applicable
PMS report / Periodic Safety Updated Report (PSUR), if applicable
Summary of Safety and Clinical Performance (SSCP), if applicable
Regulatory Gap Assessment Report, if applicable

End-to-end Compliance Support

Audit-Ready Technical Documentation

Notified Body Approval Support

Post-market Surveillance setup

Ongoing Regulatory Support

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Building compliant, audit-ready CER & PMS — together.

Let’s help you achieve it with ease.

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Our Workflow

1

Understand Your Product & Goals

Map the Regulatory Pathway

Support You Beyond Approval

Execute with Precision

Communicate Transparently

Maintain Ethics & Confidentiality

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3

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5

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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 supporting documents do I need to provide for CER preparation?

We typically require your device description, IFU, risk management file, PMS/PMCF reports (if available), and any previous CER or clinical data. If these are unavailable, we’ll guide you in gathering alternate sources or creating what’s needed.

What if my device has very limited published clinical data?

We assist in building a strong CER using a combination of internal data, post-market surveillance, risk-benefit analysis, and scientific rationale. Even with limited external data, we ensure your CER is evidence-based and justified.

What’s the difference between PMS and PMCF?

PMS is the overall post-market monitoring process. PMCF (Post-Market Clinical Follow-Up) is a specific activity within PMS to proactively gather clinical data to address gaps and confirm safety/performance over time. Both feed directly into the CER — PMS providing post-market vigilance data and PMCF supplying targeted clinical evidence.

How do vigilance reports fit into PMS?

Vigilance reports (e.g., serious incident reports) are a subset of PMS data. While vigilance focuses on urgent safety reporting, PMS looks at overall performance and safety trends, including minor incidents and feedback.

FAQs

Still got Questions? Let's talk!