Skip to content Skip to footer

MedRes Learning: Are you considering becoming a Medical Device Engineer?


In healthcare, insufficient attention to detail can mean the difference between life and death.

Having robust processes in place ensure no such details are missed, and our overall process is carved into 5 distinct phases in alignment with industry standards.

Phase 0. Concept Feasibility

• At this stage, we need to understand the customer’s product/project idea.
• As part of this, we must define clinical needs as well as understand the target market and intended users to also capture their needs.
• Once initial requirements are set, the design discovery phase starts, focusing on concept generation, prototype manufacturing, simulations and benchtop testing.
• The design discovery phase typically contains one or more concept iterations depending on the complexity of the idea.
• Typical deliverables at the end of this phase include a feasible product design, design specification and requirements specifications.

Phase 1. Design Development Planning

• In this phase, we refine the design based on test results and create project guidance documentation.
• The deliverables in this phase are the development plan and product and project documentations.
• Based on the phase review report, the project progresses to its developmental stages.

Phase 2. Development and Design Verification

• This phase focuses on ensuring that the final medical device design and development meets all the regulatory requirements outlined in ISO 13485 and FDA medical device design control regulations.
• It includes usability, manufacturability, testability analyses and selection of manufacturing methods and processes.
• To certify the product meets design, quality and regulatory requirements, several tests are completed.
• This phase ends with a frozen product design ready for validation.

Phase 3 – Design Validation and Transfer

• This phase focuses on transferring the product into manufacturing.
• It includes initial setup of supply chain, completion of planned validations and potentially clinical trials.
• The regulatory application documentation package is submitted to respective authorities, requesting their approval for the commercial release of the product.
• At the end of this phase, product development is completed.

Phase 4 & 5. Market launch and Post-Market Surveillance

• This phase prepares the product for market launch.
• The supply chain is scaled up for serial production and proper mechanisms are established to react to customer feedback as well as design changes incorporating new features.
• At the end of this phase, once regulatory approvals are received, the product is released to the clinical community.