Quality Assurance and Regulatory Affairs (QARA) Services
Strategic QARA solutions for MedTech companies to accelerate product development and achieve global market access. Elevate your regulatory strategy with our deep expertise in global submissions, DHF remediation, post-market surveillance, and more.
QARA Offerings
Adhering to regulatory standards has become a cornerstone of innovation and patient safety in the evolving landscape of global MedTech regulations. Global authorities including the Medical Device Single Audit Program (MDSAP), U.S. Food and Drug Administration (US FDA), European Commission (EU MDR/IVDR), and India’s Central Drugs Standard Control Organization (CDSCO) have introduced stricter guidelines for product safety, clinical performance, and quality management throughout the device lifecycle. As organizations pursue expansion into new markets, they must carefully navigate these increasingly complex compliance requirements.
Efficient compliance strategies help maintain a competitive edge in global MedTech markets by accelerating product development, boosting time-to-market, and avoiding regulatory penalties and reputational damage. At the same time, rising patient demands call for reliable, high-performing solutions that work seamlessly across various healthcare environments. Syrma Johari MedTech supports clients in meeting these challenges by delivering strategic regulatory guidance that promotes faster product development and readiness for global markets.
Stay Ahead with our End-to-End QARA Solutions
Regulatory Strategy & Device Classification
Quality Management Systems (QMS) & Regulatory Audits
Design History File (DHF) Remediation Services
Preclinical & Clinical Evaluation of Medical Devices
Global Regulatory Submissions & Compliance
Medical Device Labeling & Packaging Services
Software as a Medical Device (SaMD)
Materials of Concern Compliance
Post-Market Surveillance
Complaints Management for MedTech Products
Regulatory Sustenance for Medical Devices and IVDs
Regulatory Consulting & Implementation
Product Types We Support
Our regulatory and quality expertise spans a wide range of regulated healthcare products:
Medical Devices
- Electro-mechanical devices and implants
- Health monitoring and wearable medical devices
- Diagnostic devices
- Therapeutic devices
- Disposable and reusable instruments
- Imaging systems
- Neonatal and maternal care devices
Medical Aesthetic Devices
- Energy-based devices
- Electrostimulation and neurostimulation platforms
- Microneedling systems
In Vitro Diagnostic (IVD) Devices
- Clinical chemistry analyzers
- Molecular diagnostics
- Point-of-Care Testing (POCT) devices
- Self-testing kits
- Reagents and calibrators
- IVD software
Combination Products
- Drug–device combinations
- Biologic–device combinations
- Device-coated or drug-eluting products
- Wound care and regenerative products
- Cosmetic–device hybrids
Software as a Medical Device (SaMD)
- Diagnostic and decision support software
- Monitoring and predictive analytics software
- Digital therapeutics
- Algorithm-based risk assessment tools
- Mobile health applications (mHealth)
- Cloud-based health platforms
Key Benefits of Partnering with Us
Cost-efficient regulatory solutions customized to your requirements
A dedicated team of experienced QARA professionals with global regulatory expertise
Global partner network for region-specific compliance and market access
End-to-end regulatory submission support (FDA 510(k), EU MDR/IVDR, global registrations)
Comprehensive risk management services aligned with ISO 14971 across the device lifecycle
Design controls support including DHF/technical file preparation and design verification/validation
Post-market surveillance, complaint handling, and vigilance reporting across global markets
Quality Assurance (QA) services across the product lifecycle including CAPA and change control
Regulatory intelligence and horizon scanning to anticipate global regulatory changes
Audit readiness support including mock audits and regulatory inspection preparation
Digital transformation support including eQMS implementation and QMS automation
Supplier quality management including vendor audits and qualification programs
Training and competency development programs for quality and regulatory personnel
Specialized regulatory support for Software as Medical Device (SaMD) and AI/ML applications
On-demand resource allocation to efficiently scale your QA/QMS operations
Don’t let regulatory complexity slow down your innovation.
Navigating medical device regulations can be complex and time-consuming. Our experienced QARA experts simplify this process, ensuring your innovations meet global compliance standards efficiently.