design control - in short
Sufficient level of quality with Design Control
We bridge regulatory requirements, quality management and product development, so when you implement Design Control from the very beginning, you will be able to make qualified decisions in every step of the development process. This is a significant factor in executing a controlled project, in developing high quality products that meets the regulatory requirements and in meeting the deadline.
design control
Our capabilities
Whether your organization needs a single of our competences or the entire range, we are here to help you.Â
Risk Management (ISO 14971:2012)
Usability Engineering
Design Control
Requirements Specification
Traceability Matrix
Verification and Validation Plan
Test Protocols
IFU – Labelling including Instructions for Use
Assessment of Patents
Assessment of Product Specific Standards
design control - elaborated
Developing high quality products in the spread of requirements and deadlines
Development of medical devices requires a controlled level of quality, not only in the physical product but also in the documentation of the product.
Design Control at a sufficient and value adding level requires technical insight, experience and an overview of the design control process and all its elements, e.g. risk management, requirements and verification and validation activities.
Technolution can assist in planning, scheduling and executing Design Control throughout the development project. When you implement Design Control from the very beginning you will be able to make qualified decisions in every step of the development process. This is a significant factor in executing a controlled project, in developing high quality products that meets the regulatory requirements and in meeting the deadline.
Our Approach
Technolution’s consultants are experienced in bridging regulatory requirements, value adding Quality Management and the creativity of the R&D departments by executing Design Control at a sufficient level that satisfies all parties.
Technolution is in compliance with ISO 13485:2016, including Risk Management and Usability Engineering activities. Our experience in working according to a certification within our clients’ quality systems makes the cooperation efficient.
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.Â
What we do
We have nine areas of expertise that takes you from A-Z
We advise at all levels, regardless of the need for either a single competence or a full project. Depending on the size of the project, we constitute the right team of specialists.
What we do
We have nine areas of expertise that takes you from A-Z
We advise at all levels, regardless of the need for either a single competence or a full project. Depending on the seize of the project, we constitute the right team of specialists.
related cases
Cases you might be interested in:
Design Control as a discipline
Technolution’s design control specialists can quickly gain an overview of the product and the project to ensure a red thread during the design control documentation process.
A checklist for better product requirements
To avoid half-peeled potatoes, we have collected a checklist that you can use to ensure that your system requirements are not misinterpreted.
The highlights of the updated risk management standard
ISO 14971:2019 The highlights of the updated risk management standard Terminology update, most noticeably the
