Working with medical device companies worldwide, INFINETA strives to create an effective process stream from start to finish. We rely on our internal resources to deliver expert service at every juncture, generating optimal predictability and a results-oriented process.
In this initial stage, we’ll help you assess your key concept, define relevant market opportunities and identify important product requirements. This stage, which also includes early-level risk assessment and mitigation, translates into a feasible plan with robust business and operational aspects.
R&D encompasses many facets – defining specific challenges, user needs, economic feasibility, prototyping, regulation and much more – which need to be synchronized. John Keats said that “Nothing ever becomes real till it is experienced.” INFINETA operates a proven best-practice process that facilitates the ability to structure different R&D facets in a coherent manner – thus decreasing project costs and increasing product gains.
Project management is everything. Every one of our projects is managed by a dedicated project manager. Using advanced management methodology and relying on years of experience, our ultimate goal is to shorten process completion times, enhance transparency, improve communication between project facets and reduce resource consumption.
QA RA is not only an integral part of the development process, but also affects the product life cycle. As such, it is extremely important to understand the QA & RA opportunities that would support our commercial path for success.
With that in mind, our process supports QMS and Notify Body requirements – Doc control, PMS, CAPA, ECO, audits, etc. We comply with CFR 21/MDR and regulatory affairs registrations – CE, MDSP, FDA, Health Canada, China, Russia, Latin America, Australia, Japan, and emerging markets.
We like to dream big – and ground our expectations in reality. Using our lean management system, budgetary tools, cross-functional methodologies and advanced analytics, we lay the framework for optimal business results and continuous growth that anchor around predictability and profitability. We CONTROL the outcome.