Key Highlights
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- HCLTech is the preferred engineering partner to 10 of the top 10 medical devices companies and 4 out of Top 5 IVD companies
- 6500+ experienced engineers, dedicated to the Medical devices and diagnostics domain
- Knowledge and successful execution of 200+ devices, ranging from Class I,II, III
- Strong local presence in Europe with 10+ delivery centers
- 20 years of experience in medical devices alone. Several complex mission-critical electro-mechanical/ mechanical products developed from concept to launch
- Mature project and risk management processes with QMS confirming to FDA and European regulations audited by the world's leading medical OEMs
- $50Mn+ investment into generic as well as functional labs
- Partnerships with institutes such as Sri Ramachandra Institute, Velammal, SRM, Voxtur, Bio-agile for collaborative Medical Device R&D programs, Utilization of Central Diagnostic Laboratory at the Medical Centre, Animal Testing through Centre for Toxicology and Developmental Research (CEFT), Clinical Trial, Wet Laboratory Testing, Exchange of Knowledge & Experts support for Specification Development, Usability, Risk Assessment and engineering partner to Johns Hopkins University.
- Participant in Confederation of Indian Industries (CII) committee on regulatory guidelines for medical devices in India
- INTEGRATED DESIGN SERVICES- Electrical, Mechanical, Software, System and Regulatory
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Our Offerings
Sustenance Engineering Services
HCLTech has co-created 170+ Medical and IVD devices. 85% of the resources work in sustaining legacy products for 9/10 Medical Device firms. Leverage our expertise to increase product life and revenue with higher customer retention.
- Product Feature Changes
- Design to Cost
- Component Engineering
- Product Lifecycle Engineering
- Adverse Event Management
New Product Development
With capability to support end-to-end NPD lifecycle, knowledge and skill of cross functioning, get our comprehensive solution to simplify product development and redefine care.
- 1250+ Patents Filed
- Investment for in-house State-of-art Labs
- Assured Design Quality
- Experience in emerging markets devices
Regulatory and Quality Affairs Capabilities
Our Regulatory and Clinical CoEs bring in right domain expertise to provide simple and efficient approach to ensure regulatory and quality compliance.
- Highly experienced 250+ Regulatory Specialists
- Established relationship with Notified Bodies
- Supported remediation of QMS for medical device customers
- Expert Physicians within the Clinical team
Manufacturing Engineering Services
HCLTech has brought $30 MN Savings through various Manufacturing Services across various verticals. Optimize your productivity with our comprehensive portfolio of manufacturing engineering services
- Highly experienced 750+ Manufacturing Engineering professionals
- 60-70% reduction in Time in CNC Tool path programming
- 50% productivity improvement
MDR Compliance Services
Learn how HCLTech MDR Compliance Services can help to streamline your MDR journey with an efficient approach
Insights
Complaint Handling for Medical Devices
Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction.
Regulatory Challenges in Medical Device Cybersecurity
The whitepaper focuses on the challenges that manufacturers face in adopting regulatory guidelines, and discusses the solutions needed to overcome them.
Hazardous substance in Medical devices regulated by EU
The EU regulations restrict the use of various substances. This paper discusses about what are the significance and financial implications due to these restrictions, for companies wanting to market their products (Medical Devices) in Europe and how HCLTech can help them.
Key Considerations for Successful New Product Development
Every new product design and development (NPD Process) includes various aspects like understanding basic propositions, creating competitive differences, developing internal capabilities or through partners.
Manufacturing Analytics and its Application in Manufacturing Value Chain
For Manufacturing companies increasing globalization means that the supply chain has become more complex involving a multitude of suppliers, contract manufacturers, customers and other business partners.
Additive Manufacturing (3D Printing) technology in Medical Devices
This paper gives a brief Idea of 3D printing technology used in medical field and how this technology is impacting human lives and deals with basic understanding about technology involved, methods used and types of material usage and future advancements.
