Medical Device Design Software for Indian Healthcare Manufacturers
FDA-compliant, ISO 13485-aligned SOLIDWORKS solutions purpose-built for Indian medical device manufacturers. From surgical instruments to implantable devices, design with confidence, document with precision, and accelerate regulatory clearance.
Indian market size
Target by 2030
Manufacturers served
Built for Regulatory Confidence
Every feature is designed to support your regulatory strategy. Our SOLIDWORKS configurations ensure your design data meets the documentation and traceability requirements of global medical device regulations.
FDA 21 CFR Part 11
Electronic records and signatures compliance with full audit trails, access controls, and tamper-evident documentation that satisfies FDA submission requirements.
- Electronic signature support
- Full audit trail logging
- Role-based access controls
- Tamper-evident records
ISO 13485:2016
Quality management system alignment ensuring your design data, revision history, and documentation meet international medical device standards.
- Design output traceability
- Document control workflows
- Revision history management
- CAPA integration readiness
Design Controls (820.30)
Structured design control processes from planning through validation, ensuring every design decision is documented and traceable.
- Design input/output linkage
- Verification & validation records
- Design review documentation
- Transfer-to-manufacturing records
Design History File (DHF)
Automated compilation of the complete design history file, capturing every design iteration, review, and approval throughout the product lifecycle.
- Automated DHF assembly
- Version-controlled iterations
- Approval chain tracking
- Lifecycle documentation
End-to-End Design Capabilities
From concept sketches to manufacturing-ready outputs, SOLIDWORKS provides the precision, simulation, and data management capabilities that medical device development demands.
Precision Modeling
Sub-micron accuracy for implants, surgical guides, and micro-scale components. Surface modeling for ergonomic housings and biocompatible geometries.
- Sub-micron tolerance modeling
- Surface & solid hybrid modeling
- Biocompatible geometry design
- Multi-body part workflows
Simulation & Validation
FEA for stress analysis on implants, fatigue testing simulation, fluid flow for drug delivery systems, and thermal analysis for electronic medical devices.
- Structural & fatigue FEA
- Fluid flow simulation (CFD)
- Thermal analysis
- Drop test & impact modeling
Design Documentation
Automated drawing generation with GD&T, BOM management, and revision-controlled documentation that feeds directly into your DHF.
- Automated GD&T drawings
- BOM with regulatory fields
- Revision-controlled outputs
- PDF/3D PDF publishing
Data Management
SOLIDWORKS PDM for secure file vaulting, controlled workflows, and complete traceability from concept to manufactured device.
- Secure file vault storage
- Controlled release workflows
- Complete change history
- Multi-site collaboration
Solutions Across Device Classifications
Whether you are designing Class I disposables or Class III implantables, our SOLIDWORKS solutions adapt to the complexity and regulatory requirements of your device category.
Surgical Instruments
Precision-engineered forceps, retractors, scalpels, and minimally invasive tools with ergonomic grip analysis and sterilisation-compatible material selection.
Diagnostic Equipment
Imaging system housings, point-of-care diagnostic devices, lab analyzers, and portable screening equipment with thermal and EMI shielding design.
Implantable Devices
Orthopedic implants, cardiovascular stents, dental prosthetics, and spinal fusion devices with biocompatibility-focused geometry and FEA validation.
Patient Care Equipment
Hospital beds, infusion pumps, ventilators, and patient monitoring systems with human-factors engineering and IEC 60601 compliance considerations.
Consumables & Disposables
Syringes, catheters, wound care products, and diagnostic kits with high-volume manufacturing optimisation and packaging design integration.
Design Control & Risk Management
Embed quality and risk management into every stage of the design process. Our configured workflows ensure nothing falls through the cracks from hazard analysis to engineering change orders.
Risk Management (ISO 14971)
Integrate risk analysis directly into the design process. Hazard identification, risk estimation, and mitigation strategies linked to design features and simulation results.
- Hazard identification matrix
- Risk estimation & evaluation
- Mitigation strategy linkage
- Residual risk documentation
Design Reviews
Structured design review workflows with automated notifications, sign-off tracking, and meeting minute documentation embedded in the project timeline.
- Automated review scheduling
- Multi-stakeholder sign-off
- Meeting minutes capture
- Action item tracking
Change Management
Controlled engineering change order (ECO) processes with impact analysis, approval routing, and full traceability to affected components and assemblies.
- ECO workflow automation
- Impact analysis tools
- Approval chain routing
- Affected-item traceability
Real Results from Indian Manufacturers
See how medical device companies across India have accelerated regulatory clearance, improved manufacturing accuracy, and reduced time-to-market with our solutions.
Diagnostic Startup
FDA clearance in 8 months
A Bangalore-based diagnostic startup used our SOLIDWORKS-based design and documentation solution to achieve FDA 510(k) clearance for their portable blood analyzer in just 8 months -- half the industry average timeline.
Surgical Instrument Manufacturer
99.9% manufacturing accuracy
A Chennai surgical instrument manufacturer leveraged SOLIDWORKS Simulation to validate 120+ instrument designs, achieving 99.9% first-pass manufacturing accuracy and eliminating costly prototype iterations.
Implant Manufacturer
40% faster time-to-market
An Ahmedabad-based orthopedic implant manufacturer reduced their design-to-delivery cycle by 40% using integrated SOLIDWORKS PDM workflows and automated DHF compilation.
Frequently Asked Questions
Yes. SOLIDWORKS PDM Professional provides the electronic signature, audit trail, and access control capabilities required for FDA 21 CFR Part 11 compliance. Combined with proper SOPs, it creates a fully compliant electronic records environment for medical device design.
Absolutely. SOLIDWORKS is widely used for Class II and Class III devices globally. Its precision modeling, simulation capabilities, and data management tools support the rigorous design control requirements of higher-risk device classifications, including implantable and life-sustaining devices.
We configure SOLIDWORKS PDM workflows to automatically capture design inputs, outputs, reviews, and approvals into a structured DHF. Every design iteration, simulation result, and approval is version-controlled and traceable, significantly reducing manual documentation effort.
SOLIDWORKS Simulation offers structural FEA (stress, strain, fatigue), thermal analysis, computational fluid dynamics (CFD), drop test simulation, and topology optimisation. These tools help validate device performance against design requirements before physical prototyping.
Yes. CADSPro offers specialised training programs for medical device teams, covering not just SOLIDWORKS fundamentals but also medical-device-specific workflows like design controls, DHF documentation, and regulatory-aligned data management practices.
SOLIDWORKS allows custom material libraries where you can define biocompatible materials (titanium alloys, PEEK, medical-grade silicone, etc.) with their exact mechanical, thermal, and fatigue properties. These materials are then used in simulations for accurate device performance prediction.
A typical implementation takes 4 to 8 weeks, including software deployment, PDM configuration for regulatory workflows, custom template creation, and team training. More complex multi-site deployments may take 10 to 12 weeks. We provide ongoing support post-implementation.
Schedule Your Compliance Consultation
Speak with our medical device specialists about FDA-compliant design workflows, ISO 13485 alignment, and accelerating your regulatory clearance timeline.