(iii) a table compiling all observed device deficiencies that could have led to a ser ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...

Actions taken in reporting interval for safety reasons: This section of PSUR shall in ...

CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succinct doc ...

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

Sponsor or manufacturer Name and address of the sponsor or manufacturer of the inves ...

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

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