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Our Mission

"At PCS, we simplify compliance for medical device and IVD manufacturers, ensuring efficient regulatory approvals and market success."

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Our Vision

"To be the most trusted compliance partner, transforming regulatory challenges into strategic opportunities for innovation and patient safety."

Your Compliance Journey – Simplified!

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Our Five Step Journey Process

Contact PCS

Start with a quick consultation, get clarity instantly!

List Your Requirements

Share device details & compliance challenges.

Get a Quote

Transparent pricing. No surprises!

Kick-off Meeting

Strategies aligned, execution begins.

Approval & Execution

Deliverables on time, compliance achieved!

Factors that make 
Pinnacle Compliance Solutions Standout

Global Expertise

Faster approvals, flawless execution

Global Market Access

Navigate international regulations with ease

Speed & Accuracy

Faster approvals, flawless execution

Expert-Led Solutions

Our specialists guide you at every step

End-to-End Support

From planning to certification, we’ve got you covered

Our Services

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Testing Lab Services

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Electrical Safety & EMC Testing

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Specific Standard Testing

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Software Validation

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Biocompatibility Testing

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Regulatory Compliance

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Technical Documentation

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IVDR Compliance

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Regulatory Strategy & Gap Analysis

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QMS Implementation

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Testing Lab Services

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Electrical Safety & EMC Testing

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Specific Standard Testing

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Software Validation

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Biocompatibility Testing

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Authorized Representative Services

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EU REPRESENTATION

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UK REPRESENTATION

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CH Representation

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Australian Sponsorship

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Clinical Research Services

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Clinical Evaluation Reports

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Post-Market Surveillance

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Safety & Clinical Performance

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Clinical Investigation Report

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Strategic MedTech Digital Marketing

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Logo Design

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Website Development

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Lead Generation

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Active Social Media Promotion

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Online Reputation Management

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Reach Us Out!

 
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"Pinnacle Compliance Solutions” has consistently demonstrated exceptional expertise and a proactive approach to navigating complex EU regulations. Their guidance has been instrumental in ensuring regulatory compliance and achieving significant success. I recommend Pinnacle Compliance Solutions for their reliable and timely regulatory support within the EU, which has been invaluable to your organization's strategic growth and operational efficiency.

M. Viswanathan

Senior Regulatory Manager

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Ruben Velez, MD

Duncan International Private Limited

Meet Our Teams

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Praveena P

Founder & CEO

A strategic business leader with a deep understanding of medical device regulations. As the Founder and CEO of Pinnacle Compliances, she drives the company's vision to provide cutting-edge compliance solutions that enable businesses to thrive in the competitive medical device market.

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Dr. S Henry

Cardiology scientist, Scientific advisor

With a PhD in Medical Biology and extensive experience in cell and gene therapy within Cardiology, this individual has collaborated closely with medical doctors on translational projects—applying scientific and technical expertise to implement innovative strategies for treating cardiovascular disorders.

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Sivaprakash A

Principal Partner – MedTech Branding & Digital Transformation

With 15+ years of experience in digital space as a marketer and solution architect, Possess a deep understanding of the intricacies of business operations and the power of technology to transform them. As a seasoned digital marketing expert with a unique blend of solution architecture capabilities.