ISO 13485 identifies design input requirements. These requirements are:

Functional (7.3.2a)
Performance (7.3.2a)
Safety (7.3.2a)
Statutory/Regulatory (7.3.2b)
Previous and Similar Designs (7.3.2c)
Essential Requirements (7.3.2d)
Outputs of Risk Management (7.3.2e)
Customer Requirements (7.2.1)
Organizational Requirements (7.2.1)

Design inputs…[Read more]

Medical device regulations are complex, but design controls are the most complex process in any quality system. The reason for this is that each of the seven sub-clauses (Clause 7.3) represents a mini-process In fact, many companies choose to create a separate work instruction for each sub-clause.

Therefore, in terms of implementation, there are…[Read more]

According to FDA,

820.30(f) Design verification shall confirm that the design outputs meets the design inputs requirements.

820.30(g) Design validation shall be performed under defined operating conditions on initial production units, lots or batches, or their equivalents. Design validation shall ensure that devices conform to intended uses,…[Read more]