Overview

MTASK Consulting takes the complexities of Medical Device product development and converts them into effective and efficient solutions for the entire commercial product lifecycle. We navigate the medical device standards labyrinth, calling on two decades of experience to translate business, commercial and regulatory needs into engineering language and ultimately coaching companies to successfully deliver medical devices to market. Harnessing the talent within our extensive network, MTASK has the capabilities to manage the entire process for businesses – from concept, through the entire design phase, and eventually to clinical trial or market. • Business case development • Product development, regulatory and commercialisation strategy development • Coaching and mentoring for delivery to your company’s strategy • Oversight and design authority of internal and external development teams • IEC62304 Software lifecycle process support/guidance/flow • System architecture design – Class III and safety critical design • Technology review and due diligence • IEC 60601 support and design guidance • Verification planning and review • ISO 14971 support, facilitation. • QMS support throughout the medical device lifecycle • Program/project management support, coaching and guidance • Risk analysis – facilitation, support, review • Objective technical reviews • Objective design for test (DFT) reviews, design for manufacturing (DFM) reviews. • Manufacturing process reviews and oversight. • Electronics, firmware, software and mechanical expertise MTASK operates with a team integration approach. We break down the barriers between clients and external vendors and facilitate the transition from marketing, clinical, regulatory and commercial needs to product development and technical language to help find solutions and resolve conflict. Solution and outcome orientated, we believe there is NO right or wrong - or one side or the other. We find solutions for you.