ISO 13485:2016 — Medical Devices Quality Management System
ISO 13485:2016 is the international standard specifying requirements for a quality management system(QMS) specific to the medical devices industry. It helps organizations design, produce, and deliver safeand effective medical devices consistently.
Benefits of ISO 13485:2016 Certification:
- Regulatory Compliance: Aligns with global regulatory requirements for medical devices.
- Product Safety and Quality: Ensures medical devices meet stringent safety and performance standards.
- Risk Management: Supports systematic identification and control of risks throughout the product lifecycle.
- Process Consistency: Standardizes processes to maintain high-quality production and reduce defects.
- Market Access: Facilitates acceptance in global markets by demonstrating adherence to recognizedstandards.
- Continuous Improvement: Encourages ongoing monitoring and enhancement of quality management practices.
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ISO Certification Process
ISO Certification Process
Required Documents
Essential documents for ISO Certification
Registration Proof
Legal Entity Proof of your company.
Address Proof
Submit valid address proof of the company premises.
Bills & Invoices
Provide purchase bills and invoice details of operations.
Application Form
Duly filled application form for the certification process.
About us
True Quality Certification offers a wide range of ISO certifications and compliance standards to help businesses excel in quality, safety, and sustainability. We provide certifications in various sectors to meet global standards.
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