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. 

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. 

What we do

We have ten areas of expertise that takes 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.

What we do

We have ten areas of expertise that takes 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.

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