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.
Whether your organization needs a single of our competences or the entire range, we are here to help you.
Risk Management (ISO 14971:2019)
Verification and Validation Plan
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.
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.
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As Head of Design Control, Michael is ready to receive your enquiry.
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.