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ISO 13485 Conformity

Medical form with stethoscope

Medical Devices Directives

Anatomy Drawing

Whether navigating diverse invention environments to incorporate solutions within healthcare or dealing with consumer wearables and environmental applications to its regulatory compliances, DANASLA has your back. 

As engineers, who have delivered hundreds of solutions, we can assure you that if you do right from the beginning you'll stay ahead of what's to come. For compliantly harmonized medical devices it is paramount that the design and development input-to-output data demonstrates essential safety and proper use.

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Our in-depth industry and tech knowledge encompasses design and world-class medical devices, bringing value to strategic planning and execution blocks. We operate significantly faster than non-engineering design experts! How? By utilizing P-Diagram technique to create agile product management and strategy implementation.

We support medium-sized clients seeking assistance as they prepare for purposes of compliance to MDD (Medical Device Directive) and their quality management system (QMS) to the ISO 13485 standard. With the IAC (internal auditing capabilities) approach we can determine an organization's conformity to applicable, customer-specific, and national or regional regulations.

IAC for Time To Market

Featured Services:

We take a multidisciplinary approach to

  • assess developmental road-maps and performance evaluations of medical device to standards

  • assess process/product design output, DVP&R/PVP&R

  • balance the integration of engineering data and tools for decision making

  • business model product realization and design transfer 

Go Team

Comparatively, we analyze established data for suitability and effectiveness, and if improvement of effectiveness of the QMS can be made. Through internal auditing report necessary information will be provided with procedural conclusion and findings. As the result of it, organization will be enabled to establish actions to eliminate the causes of potential nonconformities in order to prevent their occurrence.

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