The Risk Management File (RMF) is a compilation of files that define how the risk of harm or loss is addressed for the product. Risk Management is mandated for medical devices, but any industry where safety and reliability are essential will benefit from a similar approach.

A manufacturer of Class III (implantable, cardiac) medical devices required remediation of their risk management files to comply with regulations based on ISO14971:2019, and EU MDR 2017/745. Policies, plans, procedures, work instructions, and reports were all provided, along with tools, templates, and in-person instruction to facilitate their implementation. All documents were provided using MS Office files to clarify communication and to avoid specialized software packages and licenses.

The Risk Management System leveraged Fault Tree Analysis (FTA) and FMEAs to support Probabilistic Risk Analysis (PRA). Evaluation of the overall probability and severity of risks drove the definition and prioritization of design, manufacturing, and usability controls identified as critical-to-risk (CTR) or critical-to-quality (CTQ). The model blended estimates with data collected by verification, validation, and usability testing, facilitating investigations and impact assessments for quality events, proposed changes, and reports from post-market surveillance.

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The Design History File is a compilation of files that detail the design history of a finished medical device. In any industry, high quality records in the DHF greatly reduce the time and effort required to conduct Corrective Action / Preventive action (CAPA) and Failure Reporting, Analysis and Corrective Action (FRACAs) activities.

A developer of Class III medical devices sought to upgrade their Quality Management Systems (QMS) to comply with the latest revisions of ISO13485, US FDA 21CFR820, Health Canada SOR/98-282, and EU MDR 2017/745. Their product design history files were also remediated and updated to comply with the latest revisions of those standards.

Mandated by regulation for Class II and Class III medical devices, detailed Design History Files benefit any company engaged in New Product Development. Quality documentation of design inputs, outputs, and design decisions streamline impact assessments for changes, upgrades, or failure investigations. This cuts development time and cost at all stages of the product lifecycle.

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Technology Readiness Assessment tailored to your company’s specific requirements can help your company assess its position against competitors and incumbents, and estimate the effort and deliverables required to get your technology to the next level. When commercializing new technologies, objective assessment of technological maturity is crucial to finding the best path to profitability.

The journey from one technology readiness level to another is unique, and not necessarily consistent when travelling from one technology level to the next. The path from benchtop concept to a ‘minimally viable prototype’ (MVP) will be different from the path between MVP and commercial viability. A Technology Maturation Plan (TMP) acts as the ‘roadmap’ to help get you there.

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Design for Reliability encompasses a variety of tools and techniques to assure that products are safe, effective, and reliable. Product-level requirements for safety, reliability and availability are cascaded down through subsystems and components, defining design and testing requirements to ensure final products are robust and reliable.

A vehicle manufacturer requested system and component reliability requirements to fit an alternative energy powertrain into an existing vehicle system. Working back from system availability and system outage risk requirements, allocations were prepared to maximize system reliability and performance, while considering component redundancy, maintenance requirements, parts-count reliability estimation, and accelerated lifetime (durability) testing for critical system components.

The results were used to define design requirements, verification tests (sample sizes, test times, stress levels) and maintenance procedures. Fault trees and FMEAs documented decisions and solutions. A Probabilistic Risk Analysis combined data from verification tests, production quality controls, environmental conditions, and human reliability testing to provide assurance that the manufacturer’s requirements could be met.

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