0102969449
ISO 13485:2016 MEDICAL DEVICES QUALITY
MANAGEMENT SYSTEM
Documents Provided
No hassle in preparation. We will provide all the documents needed for you.
Save Time & Cost
All are ready to use. No need to spend in hiring unnecessary staff and training
No Hidden Cost
No additional charges charged. Payment according to project selected
100% Satisfaction
A professional consultant will help you along the way.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices.
Benefits:
• Increase access to more markets worldwide
• Savings in cost from reduction of defects and rejects
• Meet relevant regulatory requirements and customer expectations
• Demonstrate ability to produce safer and more effective medical devices
• Improve operation efficiency through continual improvement processes
What type of organizations suitable to apply for ISO 13485:2016 ?
1. Medical Device Manufacturers 🏥⚙️
-
Surgical instruments and tools manufacturers
-
Diagnostic equipment (X-ray, MRI, CT scanners)
-
Patient monitoring systems
-
Infusion pumps and drug delivery systems
2. In-Vitro Diagnostic (IVD) Manufacturers 🧫🔬
-
Blood testing and diagnostic equipment manufacturers
-
COVID-19 test kits and rapid diagnostic devices
-
Laboratory reagents and test kits
3. Implantable Medical Devices 💉⚕️
-
Orthopedic implants (knee, hip, bone plates)
-
Dental implants and prosthetics
-
Pacemakers and cardiovascular stents
4. Personal Protective Equipment (PPE) Manufacturers 🦺😷
-
Surgical masks and N95 respirators
-
Medical gloves (latex, nitrile)
-
Face shields and protective eyewear
5. Medical Equipment and Hospital Supplies 🏨📦
-
Hospital beds and patient mobility aids
-
Sterilization equipment and autoclaves
-
Oxygen therapy equipment (ventilators, concentrators)
6. Pharmaceutical and Biotech Companies 💊🔬
-
Companies producing combination products (e.g., drug-coated stents)
-
Biotechnology firms involved in medical research
7. Software Developers for Medical Devices (SaMD - Software as a Medical Device) 💻🧠
-
Companies developing AI-based diagnostic software
-
Medical imaging software developers
-
Mobile health (mHealth) applications for remote monitoring
8. Calibration and Testing Laboratories 📊🔬
-
Third-party labs testing medical devices for compliance
-
Companies offering quality control and certification services
9. Medical Device Distributors and Suppliers 🚛🏪
-
Importers and wholesalers of medical equipment
-
Supply chain and logistics companies handling medical devices
10. Healthcare Facilities and Service Providers 🏥👨⚕️
-
Hospitals and specialized clinics
-
Home healthcare service providers
-
Rehabilitation and physiotherapy centers
11. Research and Development (R&D) in Medical Technology 🧪⚗️
-
Universities and private labs developing new medical devices
-
Clinical trials organizations testing medical innovations
Why These Businesses?
✅ Regulatory Compliance – Many countries require medical device manufacturers to comply with ISO 13485 for licensing and market access.
✅ Product Safety & Quality Assurance – Ensures medical devices meet strict safety and reliability standards.
✅ Customer and Market Confidence – Certification builds trust with healthcare providers and patients.
✅ Global Market Access – Many international markets (EU, US, Canada) recognize ISO 13485 as part of their regulatory approval process.
Would you like assistance in preparing an ISO 13485 Quality Manual, Risk Management Plan, or Internal Audit Checklist for a medical device company? 🏥📜🚀
Sample of Certification / Certified ISO 13485:2016
