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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.


Do you want to hear more, or get a non-binding offer?

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Phone: +45 51 89 68 87

Email: info@smjconsulting.dk

Stanley: stanley.jensen@smjconsulting.dk

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Vigerslevvej 242, 2. tv., 2500 Valby

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CVR: 32749542

Telephone hours

Monday - Friday: 08.00 - 16.00

Saturday and Sunday: closed