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New MEDDEV 2.5/10 EAR

6-Feb-2012 New MEDDEV guidance on European Authorized Representatives
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20-Dec-2011 - We wish you a Merry Christmas and a Happy New Year in good health.
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Successful surveillance audit

26-Oct-2011 - We congratulate one of our clients with a successful ISO13485 surveillance audit today. No nonconformities were observed.
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ISO 9001 managementsystems

Basically the ISO 9001 standard requires that you:

Plan the work that needs to be done
This means that you know what you can deliver, what your customers want and that you have the required resources (people, machines, time) available.

Control the production of products and the provision of services
This means that you provide the correct production environment, equipment, processes, test methods, etc.

Define the way your products/services are monitored
This means that you monitor the effectiveness of your activities.

Take actions to control nonconforming products and to solve problems
This includes actions taken in response to customer complaints and rejects during inspections. How do you record this information and what do you do to prevent recurrence?

Take actions to avoid problems
This includes things like risk assessments in various areas, such as FMEA for product development.

On our website we give you a brief description of the different services we can provide in the field of quality management. By optimizing your business processes you can save 10%-30% of your turnover. Our services will help you.
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