The Medical Device Quality Management Services You Need – MDR, IVDR, ISO 13485, FDA & More

MGS Design & Development is a team of dedicated Quality Management (QM) specialists with deep knowledge and a wide range of skills. These include medical device quality management systems, auditing, document review and creation, employee training and project management. We support medical device manufacturers working to meet key regulations, including the EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), ISO 13485 and U.S. Food and Drug Administration (FDA) requirements.

Our Capabilities

Whether your organization needs a single specialty or the entire range of design and development support, we are here to help ensure compliance and implement continuous improvements into your process across the product lifecycle.

Qms

Quality Management Systems (QMS)

Auditing

Auditing

Document Creation Review

Document Creation/Review

Change Management

Change Management

Training

Training

Facilitating

Facilitating

Project Management

Project Management

Advisory Service Guidance

Advisory Service / Guidance

Mdr Ivdr Transition

MDR / IVDR Transition

Creating Unexpected Business Value

A strategic approach to medical device Quality Management (QM) helps ensure that devices are safe, compliant and perform as intended in the hands of the user. Our QM team offers a range of services to support your journey toward simple and effective quality management, with a strong focus on creating business value. We do more than deliver solutions. We help put the right systems and processes in place to support long-term project success.

This approach is delivered through:

  • Extensive experience working within clients’ quality systems to develop and expand them in close collaboration with process owners.
  • Acting as a bridge between different departments to align cultures and stakeholders.
  • Breaking down organizational barriers and facilitate change, especially for larger initiatives like QMS implementation.
  • Taking on the role of project manager or stakeholder in a highly people-driven discipline.
  • Supporting medical device project expansions when scope grows beyond initial expectations.
  • Ensuring long-term ownership of quality processes by training relevant employees so the system becomes yours, not ours.

Our key goal with quality management for medical devices is to meet and ultimately exceed your expectations. This is when quality becomes more than meeting medical device regulatory requirements – it helps you 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.” 

Nancy Fonskov

Quality Management, MGS Design & Development
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We Have the Expertise to Take You From A to Z

 

Whether you need a single competence or a combination of skills, our Design & Development experts guide you through the entire process. Based on the specific needs of the medical device project, we assemble the ideal team of specialists.

We integrate advanced manufacturing knowledge into the earliest design phases and minimize iterations. Our full range of services supports your project across the entire value chain – From Imagination to Realization.

Check out all our areas of early-stage design expertise.

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