ISO 13485:2016 Consultancy
ISO 13485 Consultancy Services
We provide professional consultancy services for organizations involved in the design, manufacture, installation, servicing, and distribution of medical devices, supporting implementation and maintenance of ISO 13485:2016 Quality Management Systems in line with global regulatory expectations.
Our consultancy focuses on patient safety, regulatory compliance, risk management, and audit readiness.
Quality Management System (QMS) Implementation
- ISO 13485:2016 awareness and gap analysis
- QMS design and implementation
- Quality Manual and process mapping
- SOPs and work instructions development
Regulatory & Compliance Support
- Alignment with Medical Device Rules (MDR) / applicable regulations
- Regulatory documentation support (technical files – documentation only)
- Change management and regulatory impact assessment
- Compliance mapping (ISO 13485 vs regulatory requirements)
Design & Development Controls
- Design and development planning
- Design inputs, outputs, and review procedures
- Design verification and validation planning
- Design transfer and change control
Risk Management (ISO 14971 Alignment)
- Risk management process implementation
- Hazard identification and risk analysis
- Risk evaluation and risk control measures
- Risk management file preparation
Production & Process Controls
- Process validation and control
- Supplier evaluation and control
- Purchasing controls and supplier agreements
- Identification, traceability, and preservation of product
Sterile & Non-Sterile Device Support (as applicable)
- Cleanliness and contamination control procedures
- Sterilization process documentation (process approach only)
- Environmental control and monitoring
- Packaging and labelling controls
Post-Market Surveillance & Vigilance
- Complaint handling procedures
- Feedback and adverse event reporting systems
- Corrective and preventive action (CAPA)
- Post-market surveillance planning
Internal Audit & Management Review
- ISO 13485 internal auditor training
- Internal audit planning and execution
- Management review facilitation
- Continual improvement support
Training & Competency
- ISO 13485 awareness training
- Role-based QMS training
- Risk management training
- Regulatory compliance training
Organizations We Support
- Medical Device Manufacturers
- Medical Device Importers & Distributors
- Contract Manufacturers
- Start-ups and R&D organizations
- In-vitro Diagnostic (IVD) manufacturers
Consultancy Deliverables
- ISO 13485-compliant Quality Manual
- SOPs and process documentation
- Risk management files
- Audit-ready records and formats
- Internal audit and management review reports
Why Choose Us
- Expertise in ISO 13485 and medical device QMS
- Risk-based and regulatory-aligned approach
- Practical implementation support
- Customized solutions based on device class
- End-to-end consultancy support
Compliance & Ethical Statement
Consultancy services are limited to system implementation and compliance support.
We do not perform certification, regulatory approval, product testing, or clinical evaluation activities.
