Reduce cost of poor quality by a compliant and effective risk management
Medical device companies often struggle with the question how to implement an ISO 14971 compliant risk management process during development (pre-market) and especially during the lifetime (post-market) of the medical device.
I have the knowledge and experience to help you with a pragmatic and effective implementation. I will not only explain to you “what you should do“, but more importantly “how you can do it“, based on the intended use and design of your medical device.
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Use your QMS as an engine for improving your effectiveness and efficiency.
Medical device manufacturers need to have a QMS (Quality Management System) that complies with ISO 13485 and other standards. The QMS is often perceived by the organization as a “burden” rather than an key success factor for their business.
I have the knowledge and experience to help you with defining and implementing a lean QMS that complies with the standards, that reflects the way you want to work and that improves the quality / reliability of your products and your way of working .
Summarizing, use the QMS to become a “learning” organization.
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Safety and reliability related product defects lead to a significant cost of poor quality.
Often these product defects could have been detected and solved much earlier if the available product related databases had been analysed as “one set of data”.
I can help you with the early detection of product defects by making monitoring dashboards of your product quality and providing real time analysis functionality by combining your available product databases.
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Of course my services can be tailored to your needs.