Medical Device Design Control Services

SMJConsulting's design control services help companies comply with the design control requirements of FDA's CFR 820.30 and ISO13485:2003.

Medical design control stages from both the FDA and the ISO consist of:

Design & development planning.
Design inputs.
Design outputs.
Design review.
Design verification.
Design validation.
Design transfer.
Design changes.
Design history file.

The regulations define each stage in a linear fashion. But each requirement is actually a part of a dynamic process that can change and repeat. This is known as the design and development planning model.

Gap Analysis:

Let a SMJConsulting Specialist provide a Gap Analysis on your Design Control System.

For a fixed price we will:

Review procedures for compliance to FDA 820.30 and current industry practices
Review your Design History File(s) on selected projects.
Develop a summary report of findings, severity, and priority of findings, as well as recommendations.

Other Services:

We offer hands-on document development for the following aspects of medical device design control:

Project and V&V plans
Creation of Design Input and Design Output documents
Requirements specifications
Design descriptions.
Design Validation and Verification, including Software, including test protocols, test execution, and test records.
Risk Analysis, FMEA Analysis, FTA Analysis.
Requirements Traceability.
Design Review records.
Design Control System and Procedure Development.

Design Control Relation to FDA Submissions:

Medical devices are subject to various regulations in terms of submission and approval (FDA).
Design control deliverables are needed for the submission packages in many cases.