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Industry Focused


Faster, safer and remaining compliant. Tailored integrated regulatory, clinical and compliance solutions for medical devices and diagnostics industry.

Medical device and diagnostics manufacturers face unique challenges to comply with significant regulatory changes in Europe and the United States. The medical device regulatory landscape is evolving. New EU regulations on medical devices will come into force in May 2020.
Our integrated regulatory and clinical solutions will keep you ahead of the curve on evolving quality, regulatory, safety and compliance requirements

Technology savvy

We cover a full spectrum of innovative and complex integrated device technologies, including combination products, medical device, IVD/CDx and digital health technologies. Our experts look at the things through the device technology lens of the business.

An integrated regulatory, clinical and compliance solution

From regulatory strategy, medical device clinical trial management to post-market surveillance, VCLS provides a tailored integrated regulatory, clinical and compliance solutions to speed the approval process across regulatory, production, engineering, and quality.



Creating a Regulatory Strategy for Software as Medical Device


“Clearly VCLS knows our technology, the revised application is very clear and comprehensive. We appreciate the transparent, responsive and respectful communication. You are a great partner!”

Director of Health & Safety,
Mid-size Medical Device company

VCLS Solutions