We bridge regulatory requirements, quality management and product development to ensure a sufficient level of quality throughout
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 certified according to ISO 13485:2016, including Risk Management and Usability Engineering activities. Our certification and our experience in working within our clients’ quality systems makes the cooperation efficient.
Ole JakobsenOwner / Axlab
Development of medical devices is a long and complicated process that Technolution has carried out with great expertise.
Lars HansenGeneral Manager / PowerSense
Technolution is a competent development partner who takes on the task and delivers results beyond our expectations regarding both quality and speed.
- Risk Management (ISO 14971:2012)
- Usability Engineering (IEC 62366-1:2015 and FDA guidance on Human Factors)
- Design Control, e.g.:
- Requirements Specification
- Traceability Matrix
- Verification and Validation Plan
- Test Protocols
- Labelling including Instructions for Use (IFU)
- Assessment of patents
- Assessment of product specific standards
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