Whether you are looking for assistance with internal audit, CAPA or any other area, or to delegate the running of your entire Quality System, we can provide the most appropriate solution.
As a medical device consultancy, we understand that a good Quality Management System (QMS) is critical to patient safety and to confidence in business. Compliance to ISO13485 or US FDA regulations is just the start. A strong QMS remains up to date and is efficient, saving time rather than consuming it.
That is why we invest heavily in the state of the art, monitoring developments daily from the most relevant organisations such as the European Commission, the MHRA and the FDA. This allows us to help you to obtain and maintain QMS accreditation.
The right solution varies for each business, to protect the product and service quality without being unnecessarily burdensome. In our experience this is best achieved by building from the ground-up, rather than expecting an off-the-peg system to work straight away. We take the time to understand your operations and plan to provide a bespoke QMS ensuring smooth running and compliance. We are also experienced in e-QMS systems with their benefits in reducing administration and eliminating gaps and we can support you with this or a traditional system.
We have expertise and offer support in many areas, including the following:
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