GUIDELINES FOR THE PREPARATION OF PRODUCT DESIGN DOSSIER

 

Product Design Dossier Constitute a Chronological account of product design.

A typical product design dossiers will contain the following: -

  1. Design & Development Planning: - Planning will include-

-          Stages in design and development.

-          Design reviews i.e stages of development when a review would be carried out (to be pre decided).

-          Verification activities.

-          Validation activities.

-          Design transfer activities.

-          Responsibility- A matrix indicating the person / function responsible for design activities.

  1. Design & Development Inputs: - This may include the following

-          Functional, performance & safety requirements.

-          Applicable statutory & regulatory requirements.

-          Information derived from previous similar design where available.

-          Any other input essential for the design.

-          Risk analysis of product design.

  1. Design output: - This should be in a form that enables verification against the design & development input. This includes

-          Product drawings draft & final drawings

-          Prototype or Module where applicable.

-          Details of material.

-          Review of prototype test / performance results (FMEA may be applied).

-          Product specification and formulation.

-          Draft, product structure, such as a module outline, technical description etc.

-          Quality specifications test of method & equipments.

-          Details of design reviews i.e initial, Intermediate.

-          Clinical evaluation, if required.

-          Pre production validation This may include as appropriate:

a.       Equipment and tooling validation.

b.      Material validation

c.       Toxicology / Biocompatibility test data.

d.      Raw material & supplier validation.

e.       Stability studies as applicable.

f.       Final design review to be carried out when all design and validation is complete.

  1. Design verification data: - Evaluation of product against specification.
  2. Design validation data: - This is to ensure that the final product is capable of meeting the requirements for the intended use This includes results of clinical evaluation / evaluation of performance of the product.
Copyrights 2009. Association of Indian Medical Device Industry.