) Appendix: The appendix includes the copy of marketing authorization in India, copy ...

DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the foll ...

Identification: The manufacturer shall identify the product by suitable means throug ...

Purchasing information shall describe the product to be purchased, including where ap ...

7.4 Purchasing 7.4.1 Purchasing process: The manufacturer organisation shall establis ...

5. Clear policy on regulatory requirements, system and procedures is critical for eff ...

7.3.1 Design and development planning: The manufacturer shall establish documented pr ...

7.3.3 Design and development outputs: The outputs of design and development shall be ...