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
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
Quality Management System
Quality Management System
- 21 CFR 820, EUMDR/IVDR, ISO 13485, compliance
- QMS Development support
- SOP Authoring/enhancement
- Remote audits
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
Post Market Support
Post Market Support
- Complaints Management/Post Market Surveillance Support
- PSUR/PMSR
- Risk Management documentation support
- CER update
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
Process Quality
Process Quality
- Process validation (10/00/PQ)
- Test method Validations
- Computer System Validations (CSV)
- Change Management support
Regulations
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
