A Strategic Approach to Improving Product Performance and Longevity
Enterprises today face tremendous cost pressures to extend the life of existing products and adapt to dynamic market needs. With our services for sustenance engineering for medical devices, you can optimize your spending and improve customer satisfaction through continuous product improvement, all while staying compliant across various geographies and maintaining the highest quality benchmarks.
Sustaining Success Beyond the Launch
The MedTech industry is a continuously evolving space. Going beyond the initial launch of products, medical devices demand continuous support, enhancements and compliance updates to thrive throughout their extended lifecycle. Partner with us to cater to the evolving market needs through continuous product improvement.
Domain and technology expertise
- Talent pool of 2,500+ strong dedicated to medical devices sustenance
- A team of 100+ domain experts
- Partner to 10+ leading medical device OEMs
Dedicated Centers of Excellence (CoEs)
- Established in-house domain-specific CoEs in regulatory, medical affairs and IVD
- Generic CoEs in value engineering and reliability engineering
Solutions, accelerators and frameworks
- Electronic Device Automation Testing (eDAT), Test Automation Framework
(TAF) andCARE (Connected Assets in Regulatory Environment) — to accelerate the change implementation
Global standards and compliances
- Supported in US FDA for Class I, II and III
- EU Class I, Ir, Is, Im, Iia, IIb and III
- 60601-1, 60601-1-2, 60601-1-6 & 60601-1-8 [IEC / EN / UL / ANSI-AAMI / JIST / AS NZS / CSA]
Igniting a digital B2C sales engine for a leading hardware manufacturer
- Expertise in capital equipment, implantables, surgical instruments, diagnostic devices, medical supplies and disposables and more
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Achieve Continuous Product Improvement for Maximizing ROI and Competitive Advantage
Extend product lifespan and achieve revenue protection with margin improvements. Accomplish a state of continuous product improvement, maximize ROI and mitigate potential risks, all while staying compliant and adhering to the highest quality benchmarks with HCLTech’s end-to-end sustenance engineering services.
Post market surveillance
- Complaint data analysis (Post-market surveillance plan (PMS) plan and report
- Post-market clinical follow-up (PMCF) plan and report
- Risk management file and clinical evaluation report (CER) updates
- Summary of safety and clinical performance (SSCP)
Component engineering
- Raw material change
- Obsolescence management
- Electronic Computer-Aided Design (ECAD)/Mechanical Computer-aided Design (MCAD) support
- Identification of alternate components/ vendors
Manufacturing
- SKU rationalization
- Redesign for operations/vendor requests
- Manufacturing line/vendor transfers
- Tool/mold obsolescence
- New equipment design and IQ/OQ/PQ [installation qualification (IQ), operational qualification (OQ), performance qualification (PQ)]
Adverse event management
- Field failure analysis and CAPA (corrective and preventive action)
- Design analysis
- Design support
- Change management
- Complaints handling
Product testing/V&V
- Test method development and validation
- Compliance testing
- Environmental testing
- Reliability
- Product validation
- Design verification testing
Product cost takeout
- Teardown analysis
- Benchmarking
- Cost modeling and should costing
- Functional analysis
- Cost to function analysis
- Feature enhancements
Explore Our Latest Insights
Unlocking the benefits of AI in healthcare
Innovations and groundbreaking treatments are being developed using AI, providing a beacon of hope for millions of patients across the world
How AI is helping grow the Life Sciences and Healthcare (LSH) sector
HCLTech experimented with new options such as combining AI with various other technologies to deliver comprehensive solutions, services, platforms and products
The role of digital transformation in medical devices
With intelligence powering Medtech, decision-making becomes more certain, preventive care is more achievable and patient centricity is front and center
Accelerate your progress toward efficient sustenance and enhanced compliance with us
Leverage our sustenance engineering services by catering to evolving customer needs through continuous product improvement.