Document templates for medical devices development

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Risk Management Plan according to ISO 14971

The risk management plan is a requirement of ISO 14971 section 4.4: Risk management activities shall be planned. For the particular medical device being considered, the manufacturer shall establish and document a risk management plan in accordance with the risk management process. The risk management plan shall be part of the risk management file. You can access to our template by clicking on this link. You can also read our article about the RMP.

Software validation plan according to IEC 82304

The software validation plan is a requirement of IEC 82304 section 6.1: The MANUFACTURER shall establish a VALIDATION plan addressing all HEALTH SOFTWARE PRODUCT use requirements established in 4.2. You can access to our template by clicking on this link.

EU Declaration of Conformity

Template of EU Declaration of Conformity according to Annex IV of MDR 2017/745 and of IVDR 2017/746. You can access to our template by clicking on this link.

ISO/IEC 42001:2023 Statement of Applicability

According to ISO/IEC 42001:2023, and section 6.1.3 (AI risk treatment), taking the risk assessment results into account, the organization shall define an AI risk treatment process to produce a statement of applicability that contains the necessary controls and provide justification for inclusion and exclusion of controls. Justification for exclusion can include where the controls are not deemed necessary by the risk assessment and where they are not required by (or are subject to exceptions under) applicable external requirements. NOTE: The organization can provide documented justifications for excluding any control objectives in general or for specific AI systems, whether those listed in Annex A or established by the organization itself. You can access to our template by clicking on this link.