This procedure bundle is our updated design control procedure for compliance with 21 CFR 820.30 and ISO 13485:2016, Clause 7.3.1.
Design Controls Procedure
The purpose of this (14)-page, design controls procedure is to ensure that the product is developed in a systematic way, ensuring that risk control measures are incorporated in the design, that all design outputs are verified against specifications and validated against user requirements, and that regulatory and standards requirements are fulfilled.
The design controls procedure scope covers the design and development of new medical devices, including their packaging and labeling, and to modifications and upgrades of existing devices. This procedure applies from the approval of the initial design. This procedure is not applicable to research activities that precede design and development.
The purchase of this procedure also includes several forms and templates. The design review form is very simple to streamline your meeting documentation and simplify the process. The design requirements matrix is a fusion of two different documents used by other device companies: 1) a design FMEA, and 2) an input/output/verification/validation (IOVV) matrix. The design plan is a combined design and risk management plan. The plan combines all the requirements of: 1) a phase/gate design process; 2) the risk management activities required in ISO 14971:2019, and Annex I, sections 1-9, of Regulation (EU) 2017/745; 3) software validation documentation requirements; and 4) formative and summative usability testing requirements. The following is the full list of forms and templates provided with the SYS-008, Design Controls Procedure:
- FRM-011, Design Transfer Checklist
- FRM-018, Design Review Meeting Form
- FRM-019, Design Requirements Matrix
- TMP-021, Combined Design, and Risk Management Plan
- TMP-022, Product Requirements Template
- TMP-023, User Needs Template
- TMP-024, Design Inputs Template
- TMP-025, Verification Protocol Template
- TMP-026, Verification Report Template
- TMP-027, Risk Management Report Template
If you are interested in our design controls procedure, you might also be interested in our risk management procedure (SYS-010) and our two related training webinars:
- Design Controls Training Webinar
- ISO 14971 Risk Management Webinar- updated for ISO/DIS 14971:2018 & Regulation (EU) 2017/745
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the purchase is verified, please check your email for the download.
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