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2.0 Device description and product specification, including variants and accessories 2.1 T...

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2.0 Device description and product specification, including variants and accessories 2.1 T...

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Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succin...

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87B. Conditions of registration certificate to sell, stock, exhibit or offer for sale or ...

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Note: Configuration management is a means by which identification and traceability can be...

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

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(2) Our Authorised agent shall, — (a) act as the official representative for obtaining imp...

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(v) details of competent technical staff, under whose direction and supervision the sales ...

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6.3 Infrastructure The organisation shall determine, provide and maintain the infrastructu...

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