Building foolproof clinical documentation

Focusing on global regulatory approvals

The goal is to ensure smooth approval processes, avoid delays or rejections, and demonstrate the clinical safety, performance, and effectiveness of medical devices  across global markets.

Founded in 2015, we are fully committed to providing legal and regulatory compliance consulting and documentation services, with a strong focus on data security in alignment with ISO 17001 and ISO 13485 standards

22+

Completed projects including Legacy and New devices

Soio George

Soio George
Founder and CEO

NagaChandra Bhardwaj

NagaChandra Bhardwaj
Co Founder and CTO

Medical Device

bridging the gap: today’s clinical safety concerns, tomorrow’s patient satisfaction

Robust pre-market and post-market clinical data help identify potential safety concerns early and enable timely mitigation, ultimately enhancing patient satisfaction

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US FDA and Other Approvals

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IVDR Certificates Issued

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MDR Certificates Received

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CDSCO Success

Quality pool of full-time employed professionals

Experts in Medical Device and In-Vitro Diagnostic Device Domain

Data Collection

We gather accurate and comprehensive data through validated methods to support regulatory submissions, clinical evaluations, and post-market surveillance. Our structured approach ensures data integrity, traceability, and compliance with global standards.

Documentation

We create, review, and maintain regulatory-compliant documentation that meets global standards. From technical files to clinical reports, our experts ensure clarity, accuracy, and completeness to support successful audits and certifications.

Post Market Clinical Follow Up and Clinical InvestigationPost Market Clinical Follow Up and Clinical Investigation
Empowering Patient Safety with Ongoing Clinical Monitoring and Targeted Investigations—Your Trusted PMCF Experts from Market Launch to Long-Term Use.Empowering Patient Safety with Ongoing Clinical Monitoring and Targeted Investigations—Your Trusted PMCF Experts from Market Launch to Long-Term Use.

Trusted expertise

With industry experience and a team of experienced professionals, we deliver reliable regulatory and compliance solutions tailored to your needs.

Innovative ideas

We combine deep regulatory knowledge with fresh, forward-thinking strategies to solve complex challenges.

Quality assurance

We uphold the highest standards of quality across every stage of compliance and documentation.

Trusted Parteners

AtRegHelps, we believe strong collaborations lead to stronger results. Over the years, we have built lasting relationships with reputable organizations, laboratories, and industry experts worldwide. These trusted partners share our commitment to quality, compliance, and innovation helping us deliver exceptional regulatory solutions to our clients.