ISO 13485 : 2016

PRESENTATION OF

7.3 Design & Development

As per
ISO / TR 14969
Medical devices Quality management systems
Guidance on the application of ISO 13485:2003
 CONTINUAL IMPROVEMENT

Customer + Regulatory Requirements

Customer + Regulatory Requirements

Management
Responsibility

Resource Measurement,
Management analysis,
improvement

Product
input Product output
Realization
Process
Process
4. Quality Management System

Plan:- Establish the objectives and

processes necessary to delivery results
in accordance with customer
requirements and the organization
policies

Do:- Implement the process

Check:- Monitor and measure

processes and product against policies,
objectives and requirements for the
product and report the results

Act:- Take actions to improve process

performance
 7.3 Design and Development

7.3.9 Design and Development Changes

Improving one characteristic might have an unforeseen adverse influence on

another. For example, the following should be considered in order to help in
avoiding this situation

a) Will the product still conform to the product requirements?

b) Will the product still conform to the product specifications?
c) Will the intended use be affected?
d) Will the existing risk assessment be adversely affected?
e) Will different components of the product or system be affected?
f) Will there be a need for further interface design (e.g., physical contact with
other components in a product or system)?
g) Will the change create problems in manufacture, installation or use?
h) Will the design still be verifiable?
i) Will the change affect the regulatory status of the product?