Precision in Compliance, Success in Business

Simplify medical device regulatory requirements.

Medical Device Certifications and Approvals

HL Associates offers comprehensive regulatory solutions for the medical device industry, specializing in certifications and licenses including CDSCO (MD-05, MD-06, MD-09, MD-10, MD-15), Free Sale Certificates, MDR, ISO 13485:2016, ICMED, MDSAP, CE, UL, USFDA Listing, 510K, PMA, and country-specific registrations.

HL Associates

We are a trusted name in the industry, delivering end-to-end regulatory solutions for medical devices, specializing in certifications, licenses, and compliance to help businesses meet global standards and ensure seamless market entry.

QMS

Our QMS services optimize processes, boost safety, ensure compliance, and empower medical device companies to achieve consistent operational excellence.

Medical Devices

We specialize in regulatory consulting, ensuring certification, compliance, and quality standards for efficient solutions, product readiness, and market success.

Indian MDR

The Indian Medical Device Rules (MDR) govern the manufacturing, import, and distribution of medical devices in India, ensuring safety, efficacy, and quality in line with global standards.

US FDA 510(K)

Achieve faster market entry with expert guidance on US FDA 510K submissions, ensuring smooth approval for your medical devices.

Need Help?

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Speak to our experts

We provide Consultation, Audits, Trainings, GAP audits, Conformity Assessments, Documents Review & Testing. Supported the team Of technical experts, subject experts, trainers, and lead auditors.

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Our Clients Who Trust Our Expertise

We’re proud to work with clients who value quality, precision, and a commitment to excellence. Our clients in the medical device industry rely on us to guide them through complex regulatory requirements, and their trust is our greatest reward. Here’s to partnerships built on success!