OUR SERVICES
QMS Guru provides a wide variety of services..........
Quality system creation
QMS Guru owns a complete standard set of required documents for creating your QMS. Varying from a quality manual, quality strategies, procedures, work instructions, forms and templates for all your (business) processes. QMS Guru does not believe that there is something such as one fits all. What we try to prevent is spending time just to please the system. Contact us to get the complete overview of what we have available.
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Quality system training
We will look closely at your processes and pull out those bits of the standard that apply to you. Making sure you understand the sense of these requirements and how to apply them to your benefit.
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Qualification and Validation
Qualification and validation are about proof of concept and proof of reproducibility. For example: IQ, OQ and PQ. Most people will know these terms, but may not understand what is meant exactly and when and how to apply. QMS Guru can explain when Qualification stops and Validation begins.
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Technical file creation
What should be in your technical file for submission and how to document that? QMS Guru can tell you.
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Medical device regulation training
Complying to the medical device regulations forms an integral part of the technical file and quality system. We will create direction how to read and apply the Medical Device Directive (MDR) requirements related to your organization and product.
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General support
Do you know how to get from "A" to "B"? For example, how to select and qualify suppliers , what audits are required, how to comply to MDR requirements, how to assess what is needed for device development. QMS Guru can guide and support you to find the answers and solutions you need.
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