Services
Quality
A solid Quality Management System is the basis for all regulatory requirements. It not only gives you a “presumption of conformity”, it builds a quality culture inside your company by following a clear set of instructions and requirements. It also helps keep you on the leading edge among competitors.
ALPA Medical can help you set up a quality system based on any one of the standards below, or a combination of them. We can write, review and audit it, offer pragmatic ideas, or simply help you remove the unnecessary burden created by a heavy documentation system. We can also help with specific parts of a quality system, such as CAPA, non-conforming material, or documentation control.
- Direct with a senior lead auditor You work with Alberto himself, with no account managers and no hand-offs.
- Pragmatic, not paperwork Practical guidance that removes the unnecessary documentation burden.
- Tailored to you Every step is tailored to your product(s) and your quality system.
Our expertise
We can help you with the following
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ISO / EN ISO 13485:2016
Quality management systems for medical devices
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ISO 9001:2015
Quality management systems: requirements
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21 CFR Part 820
US FDA Quality Management System Regulation (QMSR)
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MDSAP-ready QMS
A single quality system built to satisfy MDSAP across Australia, Brazil, Canada, Japan and the USA
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Build a quality system that works
Whether you’re starting from scratch or trimming an over-heavy system, we can write, review and audit your QMS to the standard you need.