Quality Management Systems

We can help you with the following ISO 9000-based quality systems:

• ISO 9001:2008
• ISO 13485:2003
• European Medical Devices Directive (relevant annexes)

Quality Systems Assessment

Before you can follow a map you need to know where you are. We provide unbiased, independent assessments of your quality system:

• Gap Audits
• Internal Audits
• Registration Readiness Audit

Implementation Support and Project Management

Let us get your quality systems implementation project under control. Our experienced implementers provide:

• Project management
• Internal Audit Consultancy
• Expert-on-Call Service

Process and Document Development

We can show you what proper operational documentation can do for your business.

 

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