Referencer
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BiopSafe

Development of medical devices is a long and complicated process that Technolution has carried out with great expertise. Technolution’s broad know-how has meant we have a well proven product ready for the market.
Radiometer lykkedes med opgaven og startede levering inden for den planlagte deadline.

Owner, Axlab

Case

Axlab, a company supplying equipment for hospitals and laboratories, saw a need to avoid exposure to formalin in connection with taking and handling of biopsies, which causes allergies and cancer.

Existing solutions require investment of exsuction and require complex and time-consuming processes.

BiopSafe provides a unique opportunity to increase the security of the pre-analytical phase (prior to analysis of biopsy) and reduces the time spent on handling the individual biopsy.

Axlab had seen the possibility and produced the concept of having formalin in a closed system. Therefore, Axlab was looking for a partnership that could help solve the entire design, development and production task. The product is part of the IVD Directive and require a CE marking, which Technolution implemented on behalf of Axlab.

Development and marketing of this type of medical products require great demands on the compliance with standards:

  • The development of the product shall be implemented in accordance with ISO 13485
  • Risk analysis must be carried out in accordance with ISO 14971

Axlab does not have their own development department, production or quality system.

Technolution

Axlab insourced Technolution as a development partner and took the overall responsibility for:

  • Preparation of technical data to the Business Case
  • Project Management
  • Design and mechanical construction
  • Choosing material and dialogue with sub suppliers
  • Prototyping (RPT and sample molds)
  • Verification and user testing
  • Specification of production equipment and layout
  • Packaging, labels and user guides
  • Identification of producers (evaluation and selection)
  • Design transfer to manufacturer
  • Preparation of Technical File for CE marking

Solution

Technolution handled the entire process from concept to specification of production equipment and – layout as well as verification and validation of the product.

A production that can produce 5+ million units per year was established. This production is prepared to increase capacity to more than double. BiopSafe likely to be available in most of the world.

Development cooperation has been implemented in Technolutions quality system which includes the following standards:

  • ISO 13485
  • ISO 14971
  • IEC 62366

Technolution competences

Technolution has a unique combination See our competences
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of resources, which enables us to contribute to all phases of the project.

Technolution participated all the way from idea to CE marking.

We used:
Research & development
Usabiliy & design
Medical devices
Quality assurance
Manufacturing
Project management

For further information

Allan Spork

Managing Director


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