Free Medical Device & IVD Regulatory Tool Kit
Free medical device and IVD regulatory software tools to support product determination, classification, and compliance planning under MDR and IVDR.
Free Regulatory Software Tools for Medical Devices & IVDs
Patient Guard provides free medical device and IVD regulatory software tools designed to support manufacturers, start-ups, software developers, and regulatory professionals.
Navigating international compliance can feel uncertain during early-stage development phases. Our growing range of online logic engines helps simplify complex regulatory frameworks, accelerate your preliminary strategy assessments, and improve baseline decision-making accuracy before you commit to formal audit tracks.
Medical Device Determination Tool
Assess whether an innovative product, apparatus, or soft-concept layout meets the statutory definitions of a medical device under the guidelines of EU Medical Device Regulation (MDR) 2017/745 and corresponding MHRA rules.
Medical Device Classification Tool
Navigate a structured series of logical triggers based strictly on Annex VIII rules under the EU MDR. Instantly pinpoint your product's regulatory tiering and clarify subsequent technical file expectations.
Software as a Medical Device (SaMD) Tool
Engineered around MDCG 2019-11 and MDCG 2021-24 data-processing boundaries. This interactive wizard validates digital health systems, clinical workflows, and AI engines to confirm if your code crosses into a regulated environment.
Medical Device Borderline Identification Tool
Grounded in the latest MDCG parameters and the Helsinki Procedure consensus. Analyze products that sit precariously between drug delivery systems, biocides, cosmetics, or lifestyle software to isolate your explicit market path.
In Vitro Diagnostic (IVD) Determination Tool
Determine compliance under Article 2(2) criteria of the EU IVDR 2017/746. Evaluate software pipelines, clinical assay inputs, or bioinformatics platforms to definitively clarify your diagnostic classification trajectory.
