Development Strategy
Build Right the First Time. From Concept to Clinic.
Rework is the Silent Killer of Innovation
The biggest waste in MedTech is 'Documentation Debt'—building a device first and trying to retrofit compliance, quality, and regulatory requirements later.
Vague Inputs
Engineering features that don't map to validated User Needs or support viable Clinical Claims, leading to products nobody wants.
Testing Fatigue
Conducting endless 'Science Projects' instead of targeted, efficient Verification & Validation tests that satisfy regulators.
Siloed Risk
Treating ISO 14971 as a paperwork exercise, only to discover fundamental design flaws right before a major submission.
The Leanabl Insight
True speed comes from 'Flow'. We align Engineering, Quality, and Regulatory workstreams from Day 1, ensuring they move in sync and eliminating the bottlenecks that cause delays and budget overruns.
Lean Design Controls & Engineering Strategy
We provide the structural framework for your R&D team to execute efficiently, turning regulatory constraints into a competitive advantage.
Lean Design Controls
We establish clear, testable Design Inputs and create a robust traceability matrix that stands up to auditor scrutiny.
Smart V&V Strategy
We design a verification & validation strategy that minimizes sample sizes and testing costs while satisfying key standards like IEC 60601 and ISO 10993.
Integrated Risk Management
We embed Risk Analysis (ISO 14971) into your product architecture and development process, not as a final check-box exercise.
Turning Chaos into Structure
We bridge the gap between 'Agile' development and 'Waterfall' documentation.
Architecture Workshop
A collaborative deep dive focused on defining critical Design Inputs and system architecture.
V&V Master Planning
We map out the most efficient testing strategy to prove safety and efficacy without unnecessary work.
The Framework Handover
We deliver a comprehensive execution roadmap, not just a plan, for your team to follow.
Your Final Deliverables
Design & Development Plan (DDP)
Draft Design Input Requirements
V&V Master Plan
Why Trust Our Development Strategy?
Engineer-to-Engineer
We aren't just QA auditors. We understand software architecture, electronics, and mechanical constraints and speak your team's language.
Just-in-Time Documentation
We implement Lean Documentation practices, creating records when they add value, not just for the sake of paperwork.
Software (SaMD) Expertise
We offer specialized strategies for Agile software development within the strict waterfall requirements of IEC 62304.
Engineer Your Success.
Stop retrofitting compliance. Start building with a clear plan.
Start My Development Strategy