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Business Categories Covered Under ISO 13485
| Business Category | Coverage & Examples |
|---|---|
| Medical Device Manufacturers | Surgical instruments, implants, diagnostic kits, disposables, hospital equipment |
| Pharmaceutical & Biotech Companies | Pharma devices, diagnostic reagents, biotech-based healthcare products |
| Hospitals & Healthcare Providers | Multi-specialty hospitals, private clinics, nursing homes using certified devices |
| Medical Equipment Distributors & Suppliers | Importers, exporters, wholesalers, and dealers of medical devices |
| Testing & Calibration Laboratories | Labs providing product validation, safety testing, and equipment calibration |
| Dental & Orthopedic Device Makers | Orthopedic implants, dental equipment, prosthetics, and related devices |
| Sterile & Disposable Product Units | Syringes, gloves, masks, PPE kits, sterile packaging for healthcare |
| R&D & Innovation Centers | Research labs and institutions developing new medical technologies |
| Healthcare Startups & MSMEs | Small-scale innovators producing affordable medical devices for local markets |
| Public Sector & Government Healthcare Units | State and central healthcare organizations involved in procurement and distribution |
Process of ISO 13485 Certification
Application & Consultation
Choose an accredited certification body and submit your business application. Consultants review your organization’s medical device scope and regulatory requirements.Gap Analysis & Documentation
A gap analysis identifies areas of non-compliance. Based on this, essential documents like the Quality Manual, risk management plan, and SOPs are prepared.Internal Audit & Implementation
An internal audit is conducted to evaluate readiness. Staff training, risk management, and corrective actions are implemented to align with ISO 13485 requirements.Certification Audit (Stage 1 & Stage 2)
External auditors conduct a two-stage audit. Stage 1 verifies documentation, while Stage 2 checks real-time implementation of quality processes.Certificate Issuance & Surveillance Audits
After successful audits, the ISO 13485 certificate is issued, valid for three years. Annual surveillance audits are conducted to ensure continuous compliance.