QARA
The medical device industry is a rapidly changing one. OEMs have to speed up product launches, enter new markets and comply with multiple QARA guidelines to stay competitive and survive. But, the increased complexity in the regulatory landscape and differences across global regulations/requirements have become a significant bottleneck for many OEMs.
What we do
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Compliance
- DHF Documentation / Remediation
- UDI implementation
- QMS Update
- RoHS / REACH
- Risk Management Documentation
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Product & Process
- RCA & CAPA
- CDP Documentation
- DHF Usability Engineering
- Manufacturing Documentation
- Line Transfer Support
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Validation
- Design V&V
- Test Method Validation (TMV)
- Process Validation
- Computer SystemValidation (CSV)
- Component Qualifications
- Supplier Change Management
Regulatory Expertise
Diagnostic
In Vitro Diagnostic
Digital Health
Surgical
Orthopaedic
Our Key Differentiators
In-House Infrastructure
Our in-house facilities aid R&D and innovation with EMI/EMC, vibration, shock, environmental chambers, & material testing labs
Certified Solutions
The LTTS Quality Management System is ISO 13485:2016 and ISO9001:2008 certified
Consultancy Support
Alliances with accredited agencies and consultants, specializing in quality system compliance certifications like UL, CSA, and ATEX, strengthen our offerings
Extended partner network
Our partner ecosystem includes leading inspection, verification, testing and certification companies like SGS, TUV, and Intertek
RESOURCES
Brochure
Are we ready for new opportunities in medical devices? We partner with global healthcare leaders impacting 6 focus areas
Case Studies
Redesign and launch of microscopy software: We automated image alignment & illumination correction for a leading manufacturer
We successfully implementation the DICOM standard which resulted in streamlined patient data management with 30% overall savings
Virtual verification of next-gen ICU beds: We shortened release schedules by 40% with 37% CapEx savings
PoV
Read the PoV to know how Artificial Intelligence can help us change the face of Medical industry
Read the PoV to learn the What's, Why's and How's of Cybersecurity in the context of Healthcare