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If you need Quality Management or Statistical Processing, we're the people you're looking for.

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We manage the Quality of Medical Devices

Whatever are your needs in terms of medical devices regulation, we can aswer. Assistance in generating the technical file required by the 93/42 European Directive? Problems in making your process compliant with ISO 13485? Should you obtain the CE marking for your medical device software, but you don't know where to start? Do you need to build a software life cycle compliant with IEC 62304? No idea to perform a risk management analysis following ISO 14971? InerziaSoft Consulting is here to help! We can bring hardware/software medical products to the CE mark by inspecting your processes, suggesting points of improvements, building the whole technical file and finally assisting during inspections by notified bodies, whatever is the chosen annex. If necessary, we can also start your quality system management from scratch, from assessing market requirements and risk analysis to design/production, as far as to post-market surveillance and assistance.

Here's some of the things that we do

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we offer Reliability

We manage the Quality of general products and services

Nowadays, the ISO 9001 compliance for the quality system is often required even when it's not mandatory. InerziaSoft can build up your quality system completely tailored for your processes, without the overhead of introducing new procedures: we follows the "declare what you do and do what you declared" policy. Only in this situation, the next refinements will bring added values to your processes, revealing that an effective quality system is a real advantage for you and your customers: the initial cost will be more than covered by less waste, less complaints, optimization of the manufacturing cycle, reduced time-to-market in case of internal product design and development. During the system design, we can also insert the applicable quality strategy: 6-Sigma, Quality-at-the-Source, Total Quality are not just empty words for us. Every type of process can be sketched and controlled by the right quality system: from standard hardware manufacturing processes, to software design, production and deployment, to any service activity, we can help you make it better.

Here's some of the things that we do

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we love to be Professional

We do statistical processing

The true meaning of statistics is often obscure: it seems a nice try to describe what cannot be precisely described. Instead, statistics is a powerful tool for a large number of uses: the study the influence of various effects on the final results and keeping a manufacturing process under control are probably the most used. A process under control behaves in an expected way and the statistics will give you the handles to act before producing units out of the required specifications. We will analyze your process to find the method that better suit your production: from standard control charts to more complex time series (autocorrelated batch production, just as an example), we can help you to increase your knowledge of your process and to produce results always in line with expectations. A statistical output can be obtained with all processes, even for those that seems to not have measurable properties. This is in line with the ISO 9001 requirements.

Here's some of the things that we do

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We'll get in touch with you in 2-3 working days.

and we will be Delighted to work with you