VCLS has been selected as one of the experts by BPIFrance to accompany their medical device start-ups.
Regulatory challenges vary at each stage of product development – when to interact with healthcare authorities, is a pediatric development plan necessary, are clinical trial results adequate for both regulatory approval and market access, etc.? We recognize the importance of strategic analysis and decision-making in drug and medical device development. Our tailored solutions adapted to your product development stage help to successfully tackle the challenges, proactively.
We guide you throughout the complex regulatory landscape and complement your own resources, from product development strategy to market authorization and reimbursement.
We help define the roadmap to the market for health products, complete with situation audit, milestones, and the strategy needed to drive tangible results in line with corporate objectives.
We lead communication with regulators & payers. We author or review submission packages, anticipate questions from health authorities, and provide a rationale to support clients’ position before regulatory agencies and health technology assessment bodies. We are our client’s representative before health authorities. Development strategy & planning.
All pages of medical device development
Concept & Feasibility
Analyze prototype and concept design. Early development encompasses fundamental steps such as the definition of the device specifications, foreseen intended…
Evaluation of biocompatibility and safety. Analytical validation. Early clinical development is primarily composed of human proof of principle/pilot clinical studies…
Assess safety and effectiveness and gather data for registration and market access. The main objective of clinical development is to…
In Europe, CE marking procedures assess both the medical device technical file and the manufacturer’s Quality Management System (QMS) to…