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

Particular requirement for active implantable medical devices and implantable medica ...

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

Investigational medical device and methods 6.1 Investigational medical device descrip ...

Conditions for registration of medical device testing laboratory The following condit ...

3.18.2 Design validation means establishing by objective evidence that device specifi ...

Product validation and verification: The information provided in the product validati ...

7.3.6 Design and development validation: Design and development validation shall be p ...