Engineering Execution for Regulated Healthcare Products
SolidPro supports medical device and pharma organizations with structured engineering, validation, packaging, and compliance-ready delivery — enabling faster development while maintaining full regulatory control.
Our Focus Areas in MedTech & Pharma Engineering
Medical Device NPD Execution
Requirements, design outputs, prototyping, V&V readiness.
Verification, Validation & Testing
Functional, performance, safety and reliability testing.
Packaging & Labelling Engineering
Packaging design support, artwork coordination, regulatory labelling, UDI readiness.
QA/RA Documentation & Compliance
DHF, technical files, gap remediation, audit readiness.
Sustenance & Change Management
ECO execution, controlled updates, lifecycle maintenance.
Pharma Validation & Compliance
CSV, equipment qualification readiness, documentation control.
Digital Traceability & Workflow Enablement
PLM/QMS workflows, change control automation.
Our Core Solution Areas
Medical Device Product Engineering (NPD)
Structured execution from requirements through design outputs and verification readiness.
Verification, Validation & Transfer Readiness
Ensuring test evidence and manufacturing readiness are built early.
Packaging, Labelling & Compliance Engineering
Ensuring product packaging and labelling meet regulatory, usability, and manufacturing requirements.
Quality, Regulatory Documentation & Audit Readiness
Documentation execution that supports inspections and submissions.
Sustenance Engineering & Change Management
Managing ongoing product updates across active product lines.
Pharma Compliance & Validation (CSV / GxP)
Execution support for regulated pharma programs.
Digital Traceability & Compliance Workflows
Digitizing documentation and change control across healthcare programs.
Medical Device Product Engineering (NPD)
Structured execution from requirements through design outputs and verification readiness.
Verification, Validation & Transfer Readiness
Ensuring test evidence and manufacturing readiness are built early.
Packaging, Labelling & Compliance Engineering
Ensuring product packaging and labelling meet regulatory, usability, and manufacturing requirements.
Quality, Regulatory Documentation & Audit Readiness
Documentation execution that supports inspections and submissions.
Sustenance Engineering & Change Management
Managing ongoing product updates across active product lines.
Pharma Compliance & Validation (CSV / GxP)
Execution support for regulated pharma programs.
Digital Traceability & Compliance Workflows
Digitizing documentation and change control across healthcare programs.
Engineering Accelerators & Delivery Approach
Engineering POD
cross-functional teams aligned to NPD, sustenance and QA/RA programs
Design Control Execution Framework
inputs → outputs → risk → verification traceability
Digital Change Control Pack
workflow, logs, approval routing
Lean QMS Starter
ISO 13485 aligned execution support
Let's talk about your
specific use case now!
Let's talk about your
specific use case now!
Darshan Mugundhun
Practice Head - Consumer & Healthcare