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QARA

Quality Assurance and Regulatory Affairs

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  2. Industry
  3. medical device life sciences
  4. Quality Assurance and Regulatory Affairs (QARA)

Quality Assurance and Regulatory Affairs (QARA)

The worldwide demand for medical and diagnostics devices is expected to be worth over USD 720 billion by 2029. With new and more stringent regulatory and quality compliance requirements shaping the global landscape, are you, as a medical OEM, equipped to navigate the emerging dynamics?

LTTS leverages decades of deep domain experience, multi-industry engineering expertise, and a global delivery infrastructure to streamline your journey in the evolving medical device regulatory compliance ecosystem. We do more than just help your teams in regulatory submissions. Our experts and engineers align with your cross-functional units to evaluate risk, prioritize the most impactful products, and implement a business plan that makes sense for you.

We help you evaluate, integrate, and deliver across the various inter- and intra-geography medical regulations transforming and redefining the current paradigms in the process.

Our capabilities

ltts

Regulatory Compliance

Regulatory Compliance
  • Regulations/Standards gap analysis & Remediation - EU MDR/IVDR
  • RoHS/REACH/IEC/Labeling compliance
  • Biocompatibility Evaluation and Toxicological risk assessment
  • Clinical Evaluation plan and Clinical evaluation report
ltts

Quality Management System

Quality Management System
  • 21 CFR 820, EUMDR/IVDR, ISO 13485, compliance
  • QMS Development support
  • SOP Authoring/enhancement
  • Remote audits
ltts

Design Quality (New/Legacy)

Design Quality (New/Legacy)
  • Develop/ update DHF
  • Technical file preparation
  • Functional / Prototype testing / Design verification & Validation
  • Usability Engineering
  • Pre compliance/Compliance testing
ltts

Post Market Support

Post Market Support
  • Complaints Management/Post Market Surveillance Support
  • PSUR/PMSR
  • Risk Management documentation support
  • CER update
ltts

Supplier Quality

Supplier Quality
  • End to End Supplier Mngt support
  • Supplier Audits and Qualifications & onboarding
  • Virtual monitoring on Investigations & CAPA closure
  • Supplier Disengagement
  • Change management
ltts

Process Quality

Process Quality
  • Process validation (10/00/PQ)
  • Test method Validations
  • Computer System Validations (CSV)
  • Change Management support

Regulations

RoHS, MDR, IVDR, EUMDR 2017/745 Europe CDSCO Drug and Cosmetic Law India Pharmaceutical Affair Law Japan NIST framework 21 CFR Part 11 FDA QSR-21CFR820 21 CFR 820 HIPAA USA SOR/98-282 Canada

LTTS YOUR PARTNER FOR SUCCESS

30+ Years in
Healthcare

450+ Medical
Product development

Engaged with 9 of
the Top 10
Global Medical

200+ QARA
Experts

Innovation 60+ Patents generated for
Healthcare clients

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Success Stories

DHF Remediation QARA
Global Medical Devices Manufacturer Successfully Concludes DHF Remediation and Achieves Timely Compliance With LTTS’ QARA Capabilities
Discover how LTTS QARA capabilities helped a global medical devices manufacturer complete DHF remediation successfully
Explore More
Transforms Failure Reporting and Maintenance
Global Medical Products Manufacturer Transforms Failure Reporting and Maintenance with LTTS QARA Capabilities
Discover how LTTS' QARA solutions transformed a global medical products manufacturer's failure reporting and maintenance costs
Explore More
Compliant Remediation QARA
Global Medical Products Manufacturer Performs Seamless Compliant Remediation with LTTS QARA Capabilities
Learn how LTTS’ QARA capabilities helped a global medical products manufacturer achieve seamless compliance
Explore More
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