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Compliance Made Easy

With over 20 years of experience in Medical Devices, In-Vitro Diagnostic Devices, and Pharmaceutical/Combo Devices, we offer expert consultancy in regulatory compliance and training.

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Key Offerings

What Sets Us Apart

Regulatory Expertise

Our team of certified auditors and experts specialize in 21 CFR Parts 820, 210/211, 11 & 4, MDD/MDR, IVDD/IVDR, MDSAP, ISO 13485, ISO 9001, & ISO 14971. We ensure compliance through detailed audits and personalized training programs.

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Quality Management Systems

We assist in creating or revising QMS to align with the latest regulations and standards. Our eQMS implementation and validation services guarantee efficient and compliant processes.

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Project Management Excellence

Utilizing a PMI Project Manager & Six Sigma approach, we provide efficient and budget-conscious project management solutions. Our expertise ensures successful outcomes for your compliance projects.

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