QRx Partners changed its terminology for risk analysis tools to Use Risk Analysis, Design Risk Analysis, and Process Risk Analysis rather than UFMEA, DFMEA, and PFMEA.
Public source
Publisher name
Public post
Is your medical device risk analysis really just an FMEA? There's nothing inherently wrong with FMEA as a methodology. The problem is what the "F" encourages us to ask:…
Company
QRx Partners
Your expert partners in quality and regulatory success.
- Industry
- Medical Equipment Manufacturing
- Location
- Minneapolis, US
- Company size
- 11–50 employees
About QRx Partners
Your MedTech business complies with regulations because it must, and conforms to standards because it’s expected, but those aren’t the reasons you’re in business. Delivering the highest quality medical device and drug products and services is what ensures business success. So, why treat your quality management system as a necessary evil, when you should be leveraging its potential for real competitive advantage? Let QRx Partners help your quality management system to be value-added, effective, efficient, and yes, compliant. And let us ensure you can travel the regulatory pathways as quickly as possible. Services Offered: - Regulatory Submission Support - Regulatory Interaction Support - Quality System Assessment & Auditing - Quality System Development & Improvement - Education & Training - Software Solutions Services - EU PRRC Representation
See moreLatest activity
Latest activity from QRx Partners
7 signals
Presence & Recognition
QRx Partners hosted an interactive workshop on risk-based thinking and quality system decisions on Wednesday, September 30, 2026, featuring Mark Swanson and Steve Gompertz.
Presence & Recognition
QRx Partners featured Steve Gompertz on Quality Heretic discussing inspection analysis and FDA compliance.
Products & Services
QRx Partners repurposed a medical device into a candy dispenser
Discover more
Similar signals
Similar public activity from other companies.
Research & Knowledge
PQE Group
PQE Group published an article explaining how a structured Quality Risk Management (QRM) approach guides manufacturers through the four key phases of risk assessment, from identifying contamination risks to implementing controls and ongoing review, helping them meet the expectations of EU GMP Annex 1.
Research & Knowledge
Rook Quality Systems
Rook Quality Systems published its August Rook Report covering human factors submissions, biocompatibility justifications, rising 510(k) fees, and an AI-enabled wearable that cleared in 13 months.
Research & Knowledge
PRP Compliance
PRP Compliance summarized the FDA's new QMSR in a 2-minute read focusing on operations, risk-based approach, supplier controls, supply chain transparency, software integration, cybersecurity, and ISO 13485-aligned documentation.
Research & Knowledge
PROJEWX™
PROJEWX™ published a new video white paper titled Proving a Risk Instead of a Process, showing why a design control record and a batch record can't share one template and why the gap between them only surfaces during a design review or an audit.
Research & Knowledge
LANDRICH GROUP