Design Control that Delivers IVDR Compliance
Design Control (DC) is an integral part of executing a focused and successful development process for a medical device. From risk management to requirements specification, verification and traceability, our DC specialists have extensive experience with being a part of our clients’ development team, acting as co-workers on a shared mission to develop compliant and safe medical devices that fulfill user needs.
What we’ll help you with
Whether your organization needs a single competency or the entire range, we are here to help you with:
Risk Management
Product Requirements
Verification
Labeling
Design Transfer
Assessment of Product Specific Standards
Assessment of Patents
Developing High Quality Products in the gap Between Requirements and Deadlines
Demonstrating that a medical device meets the requirements for safety, regulations and intended use is at the heart of Design Control. We can assist with Design Control throughout an entire development project, which requires not only a sharp focus on controlling the quality of the physical product, but also of the product documentation.
Recently, the new IVDR (In Vitro Diagnostic Regulation) came into effect. This is one of many areas in which our specialists are ready to help your organization become compliant with the newest legislation affecting medical device development.
MGS is in compliance with ISO 13485, risk management procedures according to ISO 14971 and Usability Engineering activities according to IEC 62366-1. Furthermore, we are experienced working with a wide range of device specific standards ensuring that the medical device fulfills all pertinent requirements and regulations.
Diverse Design Control Team
Common for all our Design Control specialists is a profound technical understanding and the required expertise within Design Control. Another shared trait is our ability to end up knowing a client’s project and organization every bit as well as the client’s own employees. When engaging in a development project for a client, we always strive to meet co-workers at eye level and work within the rules and boundaries set by the organization, while holding on to our professionalism and mindset.
Design Control Requires People Skills
To succeed in helping our clients, we value people and communication skills highly. These skills are key to understanding the specific challenges in the client’s organization, and to finding solutions that comply with regulatory requirements related to the client’s product and development project. Besides communication skills, we also take pride in our technical background and expertise. We always aim to make the best possible use of the capabilities of our specialists individually, and of our broad range of other MedTech competencies in-house.
We work for and with our clients. But at the same time, it is very important for us to not just blindly do what the client tells us. We bring our own expertise to the table and therefore know how to put forth qualified solutions to the challenges of our client. Furthermore, we possess a varied and deep knowledge of the trends and innovations in the medical device industry, which we are able to bring into play during new development projects.”
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Get in Touch
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As Head of Design Control, Michael is ready to connect!
We Have the Expertise to Take You from A to Z
Whether you need a single competency or a 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.
Through deep expertise and end-to-end solutions, we are able to integrate advanced manufacturing knowledge into the earliest design phases and minimize the number of iterations. Our complete offering takes your project seamlessly through the entire value chain, ensuring faster time-to-market combined with minimized risk.
Check out all our areas of early-stage design expertise.
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