Medical Device Engineering

The medical device companies are witnessing challenges due to evolving regulations, technology advancements and globalization. Acnovate’s Medical Devices services are focused to address different challenges and help customer in improving their processes, efficiency and achieve cost reduction by utilizing Acnovates’ highly qualified and experienced resources.

Services Portfolio

  • Due Diligence (On Efficiency improvement & Cost Saving opportunities)
  • Program/Project Management
  • GS1 Labeling/UDI Support
  • PLM Services (Agile PLM, Windchill, Teamcenter & Enovia)
  • Consulting, Implementation, Integration, Migration, Maintenance, Audit & Training
  • Engineering Services
  • Concept/Industrial Design, CAD/CAE Support
  • RA & QA Support
  • Environmental/Regulatory Compliance
  • Conflict Minerals, REACH. RoHS, WEE, ELV/GADSL
  • IT Support
  • Consulting, BI, Analytics, Application Development, Maintenance & Management
  • S/W Testing, Verification & Validation
  • ERP/CRM (Consulting, Implementation, Integration)

Services across Medical Device Product Lifecycle

Design & Development

  • Concept Designing
  • 3D Parametric Modeling & 2D Detailing
  • Detail Designing, Machining, Plastic & Sheet Metal
  • GD&T Tolerance & Stack up Analysis
  • Labeling & Packaging

Verification & Validation

  • Test Method Design, Development & Validation
  • CAE Analysis
  • Mold Flow Analysis
  • Statistical Analysis (Minitab)
  • Computer System Analysis

Manufacturing Support

  • Tool & Mold Design
  • Gage, Jigs & Fixtures Design
  • Equipment, Product, Process Validation, IQ, OQ, PQ
  • Process Optimization

Sustaining Engineering

  • Product Re-engineering
  • Obsolescence Management
  • Design Change Control
  • Material Change Support
  • CAPA Support
  • DHF Creation/Remediation


QA and RA Services

Quality Assurance

  • ISO 13485 compliance support
  • CAPA Management
  • Quality Management System support
  • Supplier Qualification & Audits
  • Documentation Management
  • Risk Analysis & Mitigation

Regulatory Affairs

  • DHF/DMR Gap Analysis
  • Design Dossiers
  • Computer System Validation
  • Product, Process and Equipment Verification & Validation
  • FDA Regulatory submissions 501 (K) , IDE, PMA
  • Amendments Submissions & Supplements

GS1 Labeling Implementation

GS1 Standards are for identifying, capturing, and sharing information—about products, business locations, and more— make it possible for companies to speak the same language, connect with each other, and move their business forward. GS1 
standards, such as GTINs, GLNs and bar codes can drive supply chain speed, accountability and accuracy.


  • Due Diligence
  • Strategy & Roadmap creation
  • Budget & Resource Planning
  • Define GTIN Enumeration process and Allocation
  • Labeling Software Vendor Selection & System Assessment

Labeling System Implementation

  • Create Labeling System implementation plan
  • Create Manufacturing Site implementation plan
  • Labeling Software Testing & Validation
  • Create Labeling System Interfaces
  • Data Consolidation & Migration
  • Creating Workflow, work instructions & custom templates
  • Manufacturing Testing & Printing


  • Template Design/Layout Design
  • New Label/IFU Creation
  • Existing Label Modification
  • Label Proof Reading

UDI (Unique Device Identification) Services

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI.

  • UDI Regulation Impact assessment
  • Analyze and evaluate current systems & processes
  • Identify the gaps for a standardized system
  • Evaluate data and system integration requirement
  • Develop implementation roadmap & effort estimation
  • Identify and implement process & System changes
  • GTIN Generation Algorithms
  • Generate UDI and update master data
  • Submission of UDI data to a FDA GUDID
  • Use UDI in generating labels
  • Labeling Interface and management
  • Interface for Barcode Printing & Packaging