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To provide hands-on Regulatory and Quality assistance for small and medium-size medical device companies so they achieve a certified Quality Management System (MDSAP, EU MDR & CE Marking, ISO 13485:2016), then continue to provide resources to maintain QMS compliance and certifications.
With over 25 years of medical device Quality System development, coupled with real-world Quality and Regulatory Management experience, your company will benefit from a right-sized system.
We can meet your needs, or advise you to someone who can.
We are experts in chemical, radiological, mechanical, electrical, pneumatic, hydraulic medical devices.
Call us now if you have a device in development and need design control or regulatory product development assistance. We have over 25 years of improving speed to market timelines. HOW? By planning regulatory requirements into the project, thus capitalizing on required & correct testing Including risk reduction and mitigation.
Let us assist you in growing your business by having a QMS that is VALUE ADDED.
Read through many of our customer experiences and learn how QMS Specialists is a great fit for you! Contact us today to learn more!
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