Tailored Quality Strategies and Solutions for Your Medical Device Company
Services
Build team-centric Quality Management Systems (QMS) compliant with ISO 13485 and 2026 FDA QMSR.
Services
Custom QMS Architecture: Designing scalable, right-sized systems from the ground up for startups and global enterprises.
FDA QMSR Transition: Expert gap analysis and implementation to align legacy systems with 2026 regulatory mandates.
Digital Transformation: Selecting and optimizing eQMS platforms to automate document control, CAPAs, and training.
Risk-Centric Integration: Embedding advanced risk management (ISO 14971) into the product lifecycle to ensure continuous safety and audit readiness.
Bridge the technical gap between your engineering vision and the meticulous documentation required for regulatory approval.
Services
Comprehensive Design Planning: We establish "Right-Sized" development plans that define roles, resource allocation, and phase-gate milestones, ensuring audit readiness from the start.
Requirements Management: Expert translation of user needs and clinical requirements into measurable, verifiable design inputs and outputs.
Traceability Matrix Construction: Development of matrices that link every design input to its corresponding output, verification, and validation activity.
Verification & Validation (V&V): Ensuring test protocols and reports confirm the device was "designed right" (verification) and is the "right device" for the user (validation) using a risk-based approach for sample sizes and rationale.
Design History File (DHF)/Medical Device File (MDF) Management: Compiling and maintaining a robust DHF (referred to as part of the Medical Device File under QMSR) that serves as the definitive evidence of your controlled development process.
Design Transfer Optimization: Streamlining the transition from R&D to manufacturing to ensure production specifications consistently meet design outputs.
2026 QMSR Gap Analysis: Specialized reviews to ensure legacy design files meet the enhanced risk-management integration and terminology updates required by the February 2026 FDA transition.
My perspective on quality
I believe that people who work in the medical device industry want to deliver quality products to their customers. The friction with a Quality Management System typically stems from the lack of clarity regarding how the QMS requirements safeguards patient safety and device performance. I bridge the communication gap between development and regulatory by making technical data understandable to regulators and turning regulatory requirements into clear, executable steps for engineering teams.
Contact Us
Interested in working together? Fill out some info and we will be in touch shortly. We look forward to hearing from you!