How can we help you to increase your business value?
High-Tech medical device development is an extremely demanding process, due to the complexity of integrating various technologies in hard- and software in a highly regulated context, where safety and efficacy are topmost priorities. We offer services to help customers focus on thier ideas and products, generating value, by taking care of all required aspects to bring an idea to the market as approved medical product.
The mandatory Quality Management System (QMS) does not need to be inflexible and expensive, causing a huge amount of extra costs. Of course, quality and safety are of topmost importance, but a cost-efficient implementation of your QMS is key to enhance your competitiveness.
GKMT Consulting offers a variety of services in Project Management, Quality Management, and Technology Engineering in the medical technology sector. Special focus is placed on cost-efficient implementation of business and quality management processes by using LEAN stretegies. Increasing your business value is our priority!
for Medical Devices
We take responsibility and guarantee application of highest ethical principles, respect, fairness, and honesty. A strong, active, and positive relationship with our customers is our maximum priority, to ensure a common understanding and efficient communication.
It is unbelievably satisfying to achieve an important improvement or goal together with a customer.
Gregor Kowarik, PhD MSc PMP (Project Manager | General Manager)
Every project is unique and requires careful assessment of stakeholders, internal and external influencing factors, capacities and capabilities, and more. GKMT Consulting offers optimally tailored solutions considering all your unique circumstances and requirements.
Services
Project Management
Sucessful Project Management is a challenging task and lack of experience can easily drive costs substantially or even endanger project success. We apply best practices, principles, and methodology outlined in the global standard by the Project Management Institute (PMI) to guarantee highest reliability, state-of-the-art methods, and optimal results for your project or program management – agile, predictive, and hybrid. Our experience in medical device development and EPCM projects in the healthcare sector ensures cost-efficient and reliable outputs.
Quality Management
The regulatory framework for medical devices in Europe and the USA is tight and provides a complex set of rules for manufacturers. One major pillar of medical device development is the introduction and maintenance of a Quality Management System in accordance with the ISO13485 international standard. We offer certified Lead Auditor services for your internal audits, preparatory audits before certification, supplier audits, or expert consultancy with your Quality Management team.
Technology & Engineering
Modern integrated systems must combine cutting-edge technologies in hard-, firm- and software in rapid development cycles to keep up with the quickly developing markets and maintain compliance. Efficient integration of hard-, firm-, and software is challenging and requires strong interdisciplinary expert groups and high interaction. We can assist empowering your teams to optimize collaboration and minimize friction. The International Requirement Engineering Board (IREB) provides a standardized framework of requirement engineering techniques, ensuring delivery of optimal results in your projects.