design control - in short
Ready for IVDR? You can have our Design Control team make the compliance as one of many deliverables
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 competence or the entire range, we are here to help you with:
Assessment of Product
IFU – Labelling including Instructions for Use
Assessment of Patents
Assessment of Product Specific Standards
design control - the long read
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 force, and 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.
Technolution 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.
Want to know more?
Get in touch
Do you want to know more or didn’t you find what you were looking for?
As Head of Design Control, Michael is ready to receive your enquiry.
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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:
What you need to know about the updates to the 2019 version of ISO 14971.