Management Consultancy
From start-ups to well established companies there is always a need strategic guidance to overcome challenges, optimize operations and drive growth. We can help you to achieve your fullest potential by conducting gap assessments, helping you with your improvement targets and providing training in critical areas like, product development, validation, quality and project management to improve your decision-making, enhance efficiency and foster innovation. We are here to contribute to your organization and serve as a compass in navigating complex issues and aspiring to achieve your goals.
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Project Management
We believe that project management is change and challenge management. When companies face with change and challenges there must be a well established and effective approach to plan, manage and overcome these challenges.
It is notable that change management is at the centre of the necessary transformation, and it also appears to be indispensable. From this perspective, it does not look like change is an optional process; in other words, organisations must adapt in order to survive. That means every single company also should be familiar with Project Management methodologies and be able to utilise them when necessary.
PMforMedTech uses mainly PMI methodology that is considered as a global golden standard on project management. We also benefit from other methodologies like Agile, Lean Six Sigma and FPX (Flawless Project Execution) to support the customer needs on different projects.
Establishing a PMO
The complexities and stringent regulations governing the development, manufacturing, and launch of medical devices demand a structured and well-coordinated approach. A PMO serves as the linchpin in ensuring that projects stay on track, budgets are adhered to, and timelines are met. In an industry where even the smallest oversight can have life-or-death implications, the PMO provides a centralized hub for effective project planning, risk management, and communication. It ensures that all stakeholders, from R&D teams to regulatory affairs experts, collaborate seamlessly, aligning efforts toward the common goal of delivering safe, high-quality medical devices to patients. Moreover, in an era of rapidly advancing technology and evolving regulations, a PMO in the medical device sector plays a pivotal role in adapting to changes swiftly, staying compliant, and ultimately saving lives by facilitating the timely delivery of innovative and safe medical solutions.
Product & Process Gap Assessment
Whether it is to adhere to a new standard or a new regulation (e.g. EU MDR 2017:245 & IVDR 2017:746 Transition), or to ensure if your product is ready for submission to the authorities (for CE Marking) or to check if you QMS is mature enough for ISO:13485, MDSAP, 21 CFR 820 compliancy and audit preparation we can guide your organisation along the way to ensure guaranteed results.
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