QNRS exists to solve critical issues facing our clients, both large and small. Our unique expertise and approach are not only what differentiate us, but also what make us and our clients successful. We provide a broad range of services and solutions to help organizations accelerate their success and improve people’s lives.
Quality Services
QNRS provides quality services to the medical device industries. Below is a short list of Quality Services we offer:
- Regulatory Inspection preparations and support -FDA, CFDA/NMPA
- QMS Establishment, QMS Remediation
- Risk Management (ISO 14971, NIST SP 800-37)
- Cybersecurity Risk Management (AAMI TIR 57, AAMI TIR 97, NIST-SP 800-39, SP 800-53, etc.)
- Design Control, Design History Files (DHF)
- QMS Development and Implementation (ISO 13485, ISO 9001)
- Information Security Management System (ISO 27001, SOC2, SOC3)
- CAPA, RCA, and Problem Solving
- Software Development Lifecycle (SDLC) (IEC 62304, IEC 82304, AAMI TIR 45)
- Equipment / Process Qualification and Validation (IQ, OQ, PQ)
- Computerized System Validation (CSV/CSA)
- Technical Files Compilation (EU MDR, MDD)
- Quality Engineering
- Quality Audit Readiness Preparation, Execution, Hosting, and Support
- Regulatory and Quality Assessments
- Usability Engineering (IEC 62366, HE75)
- Quality Data Analysis, Statistical Techniques
- Acquisition Due Diligence
- QMS Integration
- Training
Regulatory Services
QNRS provides regulatory services to medical device industries. Our services include:
- FDA 510(k) Submissions
- FDA Pre-subs
- FDA 513(g) Submissions
- Regulatory Strategies and Pathways
- Establishment Registrations, and Device Listings
- Notified Bodies
- UDI Compliance
- International Registrations (South America, China, Europe, Canada)
- CE Marking
- Tech File/Design Dossier
- FDA US Agent Services
- Canada MDL/MDEL
- IEC 62304 compliance
- IEC 62366 Compliance
- Clinical Evaluation Reports
Remediation
QNRS has successfully helped companies remediate:
- FDA 483 observations
- FDA Warning Letters
- FDA Consent Decree
Issues remediated include:
- QMS
- Risk Management
- Design Control
- DHF
- CAPA
- Production and Process Controls
- Purchasing Control
- Supplier Management
- Recalls
- Complaint Handling / MDR
- SDLC
- 21 CFR part 11 compliance
- Software Validation/CSV
- Quality Planning
Risk Management
QNRS provides expertise that help companies stay in compliance with Risk Management Standards ISO 14971 throughout the whole product realization lifecycle:
- Develop product life cycle Risk Management Plan and strategy
- Integration of Medical Device safety risk management with cybersecurity risk management
- QMS process integration with Risk Management to enable risk-based decision making
- Cybersecurity Threat Modeling Analysis and Risk Controls
- Identify and assess hazard / hazardous situations and harms
- Analyze and evaluate causes and contributing factors
- Identify and implement risk controls and mitigations
- Evaluate risk control and mitigation effectiveness, and overall residual risks
- Compile Risk Management Report