Relationship between ISO 13485:2003 and CE Marking

01

ISO 13485:2003 Clause 4.2.1

The organization shall maintain a file containing documents defining the product specifications

02

ISO 13485:2003 Clause 4.2.4

Records must be maintained at least equivalent to the lifetime of the medical device, not less than 2 years.

03

ISO 13485:2003 Clause 6.4

Would cover all those requirements within you QMS for manufacture of a sterile device. OBL manufactures also need to validate the sterilization process

04

ISO 13485:2003 Clauses 7.1 & 7.3

Risk Management and Design Control to be documented

05

ISO 13485:2003 Clause 7.4.1

Supplier control, especially if you are outsourcing any critical process

06

ISO 13485:2003 Clauses 7.5.1 & 7.6

Sterile devices requirements related to sterilization need to be added into QMS, also installation, service, validation of processes, label and traceability requirements, etc.

07

ISO 13485:2003 Clause 8.2.1

Feedback /complaint handling analyzed with Post Market Surveillance

08

ISO 13485:2003 Clause 8.2.2

Internal Audits should have of auditing the MDD requirements

09

ISO 13485:2003 Clause 8.5.1

National or regional requirements for adverse events, documented procedures must be written

More about ISO 13485:2003

INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp


mail enquiry@i3cglobal.com

Skype Me�!
LiveZilla Live Chat Software
call me back