Smarter route to market for safer, de-risked, compliant and innovative products. We offer tailored integrated regulatory, clinical and compliance solutions for the medical devices and diagnostics industry.
Medical device and in vitro diagnostic (IVD) manufacturers face unique and individual challenges to comply with significant regulatory changes in Europe and the United States. The medical device regulatory landscape is evolving, and yet there are significant distinctions. For example, FDA’s established combination pathway for approval of a drug-device (biologic-device) establishes the responsible lead review Office at FDA based on the primary pharmacological mechanism, allowing a single IND to cover aspects of both the drug (biologic) and device under a single application.
New EU regulations on medical devices and IVDs entered into force in May 2017 with staggered deadlines to transition, applicable to products already on the market, subject to risk classification of the devices. At the same time, US FDA is focusing on innovative technologies, exploring novel regulatory pathways and approaches to the increasingly fast paced medical device industry. International harmonization is also an initiative FDA is pursuing, for example through alignment of their Quality System Regulation with the internationally recognized ISO 13485 standard. Harmonization initiatives are being pursued by MHRA as well, in light of Brexit and the development of a new UK regulatory framework that focuses on safety, availability of devices and the needs of the industry.
Our integrated regulatory and clinical solutions will keep you ahead of the curve on evolving quality, regulatory, safety and compliance requirements in established medical device regulatory markets.
Technology savvy
We cover a full spectrum of innovative and complex integrated device technologies, including combination products, medical devices, IVDs/companion diagnostics (CDx) and digital health technologies. Our multidisciplinary team of experts view things from a fresh perspective but always through the device technology lens of the business.
An integrated regulatory, clinical and compliance solution
From regulatory strategy, medical device clinical investigation management to post-market surveillance and vigilance activity, VCLS provides a tailored integrated regulatory, clinical and quality compliance approach to speed the approval process across regulatory markets. This includes solutions supporting product development, engineering, manufacturing, clinical validation as well as quality compliance throughout the organization.
Medical Device Drug-device Combinations In-vitro Diagnostics
Companion Diagnostics Digital Health Technologies
“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 Client
Solutions 
