Project Charter & Development Plan
Define objectives, scope, roles, deliverables, milestones, assumptions, and success measures.
SERVICES
Clear support for complex MedTech work
Choose the service area that matches your current project stage. Services can be scoped as focused deliverables or broader project support.
Design Controls & DHF Remediation
Structure design inputs and outputs, verification and validation evidence, traceability, and design history documentation.
R&D & Feasibility Studies
Support feasibility planning, technical evaluation, development evidence, and design decision documentation.
Manufacturing Engineering & Design Transfer
Prepare processes, documentation, acceptance criteria, and cross-functional handoffs for manufacturing.
Quality Systems, CAPA & NCR
Support nonconformance investigations, corrective actions, audit preparation, and quality-system improvements.
Risk Files & Technical Files
Organize risk-management evidence and technical documentation packages for regulatory submissions.
Post-Market Surveillance
Support complaint trending, post-market processes, signal evaluation, and documentation readiness.
Design for Manufacturability
Connect design decisions with process capability, production constraints, and practical manufacturing needs.
Combination Products
Cross-functional support for products combining medical-device and pharmaceutical considerations.
Regulatory Submissions: SFDA, FDA & Global Markets
Project-based support to plan and prepare medical-device regulatory submission packages for Saudi Arabia's SFDA, the U.S. FDA, and other country-specific regulatory authorities. Scope may include pathway and classification research, submission checklists, document coordination, gap reviews, and response-readiness support.
Regulatory Technical File Readiness
Assess technical-file completeness and readiness before submission. Support can include gap assessments, document indexing, evidence and traceability reviews, risk-management documentation, design verification and validation records, labeling, clinical/performance evidence, and post-market documentation, as applicable to the product and market.
FDA product codes and classification regulations are device-specific. Use the FDA Product Classification Database links above to search by device name or product code; confirm the intended use, indications, device class, regulation number, and submission pathway for each specific device. These links are educational resources, not a determination or guarantee of FDA classification or clearance.
FDA QMSR / 21 CFR Part 820 deliverables
Structured, risk-based support for applicable quality-system and design-control documentation. Scope is tailored to the product, intended use, and regulatory pathway.
Project initiation & planning
Project charter, Design and Development Plan, development milestones, team responsibilities, design reviews, and deliverable ownership.
Design inputs & outputs
User needs, measurable design inputs, acceptance criteria, design outputs, specifications, traceability matrices, and review records.
Verification & validation
Design V&V plans and protocols, objective evidence, test reports, usability engineering, formative and summative evaluations, and feasibility-study planning/documentation.
DHF remediation & traceability
Gap assessments, remediation plans, design history file organization, risk-to-requirement traceability, and evidence closure.
Manufacturing setup & transfer
Manufacturing process setup, work instructions, equipment and process qualification planning, acceptance criteria, DFM, and design-transfer readiness.
Project & people management
Integrated plans, schedules, risks, stakeholder alignment, cross-functional leadership, resource planning, metrics, and delivery follow-up.
Clinical feasibility & surgeon feedback
Experience includes traveling with Marketing teams to engage surgeons, demonstrate products, gather voice-of-customer and workflow feedback, and translate user needs into product redesign inputs. Activities can support feasibility and usability planning; clinical activities require the appropriate approvals and protocols.
Analytics & engineering software
Power BI dashboards to visualize device performance and track metrics; project and quality systems including Agile, eQMS, Adaptive, ETQ, and Windchill; CAD/CAE tools including Siemens NX (Unigraphics), SolidWorks, Pro/ENGINEER, ANSYS, and Fluent.
Each engagement is scoped to the product, target market, project stage, and available evidence. Regulatory outcomes are not guaranteed.
Not sure which service you need?
Describe the challenge and we'll help define a practical scope.
Discuss your project →Tools, systems & data workflows
Practical experience across enterprise systems, quality platforms, analytics, engineering software, and project-delivery workflows. The exact tools used are selected to match the client's environment and access.
Enterprise & operational systems
SAP / ERP, Excel-based operational tracking, and coordination across business and technical teams.
Quality & document systems
eQMS, EDMS, ETQ, Windchill, quality documentation, change control, CAPA/NCR records, and design-history-file traceability.
Analytics & project delivery
Power BI dashboards, SQL, Python, Minitab, Excel, Adaptive, Agile project workflows, milestone tracking, and performance reporting.
Engineering & simulation
Siemens NX / Unigraphics, SolidWorks, Pro/ENGINEER, ANSYS, and Fluent for design, engineering evaluation, and simulation workflows where applicable.
Product lifecycle & manufacturing
Manufacturing Execution Systems (MES), manufacturing readiness, design transfer, design for manufacturability, and post-market metrics.
Business productivity
Microsoft Word, Excel, PowerPoint, OneNote, structured reports, presentations, and controlled project documentation.
Tool glossary: explore the systems
Select any tool to open its official product page, documentation, or introductory explanation in a new tab. These links explain the tools; they do not imply vendor endorsement or that every platform is included in every engagement.