Quality management - in short
MDR, IVDR, ISO13485, FDA & even more - you will find them all at the core of our capabilities
A strategic approach to Quality Management (QM) is key to ensuring that a medical device is safe, compliant and works as intended in the hands of the user. Our QM team offers a range of capabilities supporting our clients’ journey towards simple and effective quality management with a clear focus on business value creation.
Dive into our capabilities
Whether your organization needs a single competence or the entire range, we are here to help you. Read more about our capabilities.
Document Creation / Review
Advisory Service / Guidance
MDR / IVDR Transition
Quality management - the long read
Creating unexpected business value
At Technolution, we are a team of dedicated quality management specialists with deep knowledge within a wide range of capabilities – e.g. auditing, document review and creation, employee training and project management. Several of the team members have 25+ years of experience within the medical devices industry.
We have extensive experience working within our clients’ quality systems to further develop or expand the systems in close cooperation with the process owners. A signature trait of our team is the ability to act as bridgebuilders or mediators between different kinds of departmental cultures and people within an organization. Quality management is a highly people-oriented discipline, and we have taken on the role as project manager or stakeholder for numerous clients throughout the years. Being able to break down barriers within the organization and facilitate change is especially important to the success of larger quality management projects such as the implementation of a new quality management system (QMS).
In addition, the QM team members are ready to take the next step, when a project gradually expands and becomes more comprehensive than initially expected by the client. This is, in our experience, the case for many client projects. Furthermore, we are very much aware of the risks associated with leaving the client at the end of a project without securing the proper ownership of the management system processes. This involves training the relevant employees and thereby ensuring that the system and process ownership is not ours, but yours.
A key goal with quality management is to meet and ultimately exceed customer expectations. This is when QM becomes more than meeting regulatory requirements – it helps organizations create more business value. Our team has the required level of business understanding to make this a reality.
It’s a common myth that quality management people are a bit like police officers. At Technolution we take a different and more pragmatic approach. Our people know that their job is not to change each and every process in an organization, but rather to understand the clients’ current state of quality management and together work out the next step. What we do, has to make sense to the client, and we often end up creating business value that the client didn’t expect in advance.” – Nancy Fonskov, Head of Quality at Technolution.
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What we do
We have ten areas of expertise that take you from A-Z
Whether you need a single competence or any combination of skills, our experts are ready to assist you through the entire development process. Based on the specific needs of the project, we assemble the ideal team of specialists.
Cases you might be interested in:
9 product families submitted for approval in timely MDR transition project
Transitioning from MDD to MDR compliance touches on several different business processes – all happening within a strict deadline. Therefore Ambu A/S decided to initiate the process well in advance and team up with Technolution..
Medical device regulations: obstacle or golden opportunity?
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.