MDR, IVDR, ISO13485, FDA & More – We’ve Got the Quality Management Resources You Need
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.
Our Capabilities
Whether your organization needs a single speciality or the entire range of design and development support, we are here to help you. Read more about our capabilities.
QMS
Auditing
Document Creation/Review
Change Management
Training
Facilitating
Project Management
Advisory Service / Guidance
MDR / IVDR Transition
Creating Unexpected Business Value
At MGS Design & Development, we are a team of dedicated quality management specialists with deep knowledge within a wide range of capabilities – auditing, document review and creation, employee training and project management. Several of our talented 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. We act as bridge builders 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. 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 quality 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 MGS Design & Development 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.”
WANT TO KNOW MORE?
Get in Touch
Do you want to know more or didn’t you find what you were looking for? Get in touch with our Quality Management team.
We Have the Expertise to Take You From A to Z
Whether you need a single competency or a combination of skills, our experts in Design & Development are ready to assist you through the entire process. Based on the specific needs of the project, we assemble the ideal team of specialists.
We are able to integrate advanced manufacturing knowledge into the earliest design phase and minimize the number of iterations. Our complete offering takes your project seamless through the entire value chain – From Imagination to Realization.
Check out all our areas of early-stage design expertise.
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