What is ISO 13485:2016 Certification?
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems specifically designed for the medical device industry. It ensures regulatory compliance with FDA, EU MDR, and global medical device regulations while demonstrating the organization's ability to consistently provide safe, effective medical devices that meet customer and regulatory requirements. Our expert ISO 13485 consultants in Hyderabad provide complete medical device QMS implementation, regulatory compliance support, documentation, ISO 13485 training, and certification assistance.
ISO 13485 medical device certification is essential for manufacturers, distributors, and service providers in the healthcare industry. Applicable to all types of medical devices from Class I to Class III, implants, diagnostics, and medical equipment. AP Assessment and Certifications offers professional ISO 13485 certification services in India and internationally.
Benefits of ISO 13485:2016 Certification
Global Regulatory Compliance
ISO 13485 certification ensures compliance with FDA 21 CFR Part 820, EU Medical Device Regulation (MDR), Health Canada, TGA Australia, and other global medical device regulations and quality system requirements.
Market Access
Access international markets for medical devices.
Risk Management
Systematically identify and control medical device risks.
Product Safety
Ensure consistent production of safe medical devices.
Customer Confidence
Demonstrate commitment to quality and safety.
Compliance Documentation
Maintain comprehensive documentation for regulatory audits.
Who Needs ISO 13485:2016 Certification?
- Medical Device Manufacturers
- IVD Manufacturers
- Medical Device Distributors
- Healthcare Providers
- Pharmaceutical Companies
- Medical Equipment Suppliers
- Clinical Laboratories
- Research Organizations
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