XXX, Inc.

identifies the following requirements of ISO 13485:2003 as not applicable,

and as exclusions to our Quality Management System:

Requirement Rational
7.3 Design & XXX, Inc. manufacturers to customer’s specification and
Development does not participate in the design or development of
their products
7.5.1.2.2 Installation XXX, Inc. is a contract manufacturer of components and
does not offer installation services
7.5.1.2.3 Servicing Same as above
7.5.2.2 Sterilization Products are supplied clean to customer’s
specifications. Sterilization is not a requirement
7.5.3.2.2 Active & XXX, Inc. products are components and not stand
Implantable alone finished products. In some cases the end product
in unknown.