Global Medical
Device CDMO

Before entering the design controls process, we work
closely with clients to create functional prototypes that
explore device capabilities and can be tested for usability.
These activities support rapid design iteration and
verification while maintaining the critical product
requirement documentation to be leveraged in
subsequent project phases.

We establish a framework and regulatory strategy at the
start of the design control process to guide the project
and leverage FDA feedback through pre-submission
communications. This planning ensures that milestones,
responsibilities, and design activities are clearly defined
by companies and the functional groups involved.

When developing a medical device, it is essential to
clearly define the intended use and user needs. We
establish measurable functional requirements to assess
performance, safety, reliability, and other key attributes.
These design inputs later serve as criteria for evaluating
design outputs and the overall product design.

Activities in this phase focus on designing a product that
will meet the design inputs. This stage includes extending
and finalizing the prototype design through 3D CAD
models and 2D drawings, conducting risk analyses,
formalizing test methods to evaluate device performance
against requirements, and developing labeling and
packaging. This stage serves as the foundation for the
DMR (Device Master Record). At the end of the phase,
design freeze occurs in preparation for device verification
and validation testing.

Now, we select manufacturing equipment and fixtures, set
process parameters, create assembly instructions, and
identify critical inspections based on risk analysis. We
develop design verification and validation protocols from
earlier requirements and test accordingly. The regulatory
documents compiled from documentation across our
process can then be submitted to regulatory authorities
for clearance and approval.

This phase ensures the product design is properly
transferred from design into manufacturing in preparation
for commercial production. Process equipment is formally
qualified (IQ/OQ/PQ), DMR documentation is transferred,
and manufacturing team members are trained. A Quality
Plan outlines the required incoming, in-process, and final
product release testing necessary for production.