Healthcare and Medical Device Companies, Product Design and Engineering Teams, Pharmaceutical Companies, User Experience (UX) Teams, Regulatory Compliance Teams, Quality Assurance Teams, Project Management Teams, Human Factors Service Providers, MedTech Startups, Product Design & Development, Regulatory Affairs
Boost Success in MedTech Product Development
We understand the nuances that make medical human factors projects succeed. Reduce risks by infusing industry-focused, fit-for-purpose capabilities, designed to carefully and efficiently align you with key standards (ISO 13485, IEC 62366-1...) and best practices.
Project Lifecycle Management & Optimization
Rooted in the pioneering framework Successful Human Factors 2.0, we skillfully handle the intricacies of your human factors projects, offering a unique systematic approach and tailored execution. Enhance your team’s capabilities and empower them to focus on mission-critical work.
Network of Quality-Oriented HF Partners
HF Vendor Matching
SHF 2.0 Empowered PM
HF Project Managers
Strategic HF Program Management
HF PMO Solutions
ISO 13485 Alignment: Supplier Audits, Project Health Check & Remediation
Rise Above Inconsistent Outcomes
According to a study conducted by Rojas et al., it was found that 70% of participants who employed structured project management for human factors validations encountered zero rejections in their FDA submissions. In stark contrast, all respondents lacking formal project management reported experiencing submission rejections.
According to FDA data, failure rates per HF submission type are as follows: 96.1% for Q-sub, 93.5% for PMA, and 89.5% for 510(k).
All medical products manufacturers experience delays in completing HF projects, and a significant 70% of HF service providers or consultancy firms encounter similar challenges.
HOW WE DO IT
Pioneering Industry-Focused Framework Based on Key Standards & Success Factors
Our services drive human factors project success by leveraging the industry-focused SHF 2.0 framework. This trailblazing framework, developed through our pioneering research, integrates proven project management practices with essential human factors pillars. Through groundbreaking work, we characterized the key SHF 2.0 categories: Planning and documenting, People, Tools and methodology, Timing and integration, Communicating and Reporting.
By leveraging our research-based proven framework, we impart the key success factors for excellence in human factors project delivery. This equips teams with the insights and tools to manage complexity and achieve strategic objectives.
Clients gain a competitive advantage when they partner with us, as our services are built on a uniquely tailored framework designed to meet their specific needs, masterfully aligning them with key practices and industry standards (ISO 13485, ISO 14971, IEC 62366-1).
Key Success Factors
We pioneered the identification of key best practices for successful human factors engineering projects through original, rigorous research and collaboration with leading HFE experts.
For a Limited Time
Align with best practices and key industry standards such as: ISO 13485, ISO 14971, IEC 62366-1…
Complimentary & Confidential Assessment
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