Regulatory and Quality Services
Home – Regulatory and Quality Services
QMS Compliance
- QMS Gap Assessment (ISO 13485, QMSR, MDSAP)
- QMS Implementation & Remediation
- Audit & Inspection Support (Internal, Supplier, and Certification)
- Certification & Regulatory Compliance (ISO 13485, MDSAP)
- Computer System Validation
- QMS Processes Validation
- Quality Assurance & Continuous Improvement
Regulatory Services
- Global Regulatory Strategy: EU MDR/IVDR, US FDA, UKCA, TGA and international market access.
- Domestic Regulatory Strategy: CDSCO Licenses & Certificates, BIS Approval.
- Quality Management & Certifications: ISO 13485, MDSAP, QMSR, Internal Audits, CAPA Risk Based Approach and quality system implementation.
- Technical Documentation & Submissions: Design History File, Technical Files, Risk Management File, and Regulatory Dossiers.
- Testing, Verification & Validation: EMC/EMC, Electrical Safety, Software Lifecycle, Biocompatibility, Stability Study, Transportation & Packaging and Sterilization Validation.
- Post-Market & Lifecycle Compliance: PMS, PMCF, Vigilance, Adverse Event Reporting and Post-approval Change Management.
Training
We can train your team on following.
- Clinical Investigation Report
- CER and Literature Search Report
- Biological Evaluation Plan & Biological Risk Evaluation Report
- Toxicological Risk Assessment
- Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR)
- Post Market Clinical Follow-up (PMCF)
- Instruction for Use & User Manual
Medical Writing
- QMS (ISO 13485, MDSAP)
- Usability (IEC 62366)
- Risk Management (ISO 14971)
- Design Control (21 CFR Part 820 & QMSR)
- Software Development Life Cycle (IEC 62304)
- EU MDR 2017/745 & IVDR 2017/746,
- Cybersecurity (AAMI TIR57:2016)
Authorised Representative
in absence of establishment and Local agent in India, Sinnov8 can serve as an authorised agent and can provide you with all the necessary assistance throughout the process of import to launch your product in time.
Labeling and Technical writing
- Labeling intelligence & Global harmonization strategy
- Global UDI compliance
- Country specific labeling compliance
- Labeling Symbology Management
- Technical Writing Services
