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Quality Management – When standards are essential

Our certified Quality Management system gives you reassurance and ensures a high, consistent quality. It covers all aspects of our services. We integrate it in the development processes as well as the products themselves.

When you implement QA from the very beginning you will be able to make qualified decisions in every step of the process. This will lead to a high quality product that meets the regulatory requirements and standards. From planning to assurance, control and improvement.

We are certified according to ISO 13485: 2016. Our certification and our experience in working within our clients’ quality systems make the cooperation with certified businesses efficient.

Furthermore, Technolution offers implementation of quality management systems in new businesses.

Technolution’s consultants are experienced in bridging regulatory demands, the creativity of the R&D departments and quality management.

Ole Jakobsen

Owner / Axlab

Development of medical devices is a long and complicated process that Technolution has carried out with great expertise.

Lars Hansen

General Manager / PowerSense

Technolution is a competent development partner who takes on the task and delivers results beyond our expectations regarding both quality and speed.

ISO13485

We've got your back

ISO 13485:2016

Medical devices – Quality management in the development of medical devices

Our certification and our experience in working within our clients’ quality systems make the cooperation with certified businesses efficient. Technolution’s quality management system is also in compliance with the following standards:

 ISO 14971:2012
Medical devices – Application of risk management to medical devices
IEC 62366:2007
Medical devices – Application of usability engineering to medical devices
ISO 15378:2012
Primary packaging materials for medicinal products
MDD 93/42/EEC
Medical Device Directive
 
IVD 98/79/EC
In Vitro Diagnostics Directive
FDA CFR820
Coming soon – spring 2018

Let's have a look at your next quality management project. Reach out to

Michael Tokeskov Mikkelsen ‧ head of QA

Give MICHAEL a call    or   Drop him a line

Our Capabilities

  • Risk Management (ISO14971)
  • Design control
  • Internal audit, supplier audit and support to Notified Body audit
  • Integration of business and quality processes

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See more cases or get more insight

 

These are our domains of expertise

Mechanical engineering      Usability engineering      User experience & Design      Test & verification      Quality management      Business development