ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS CERTIFICATION
ISO 13485:2016 is an international standard for quality management systems specific to the medical device industry. This standard sets out the requirements for a comprehensive quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices. Obtaining an ISO 13485:2016 Medical Devices Certificate is crucial for organizations looking to demonstrate their commitment to producing safe and effective medical devices that comply with regulatory requirements.
In the medical devices industry, safety and quality are non-negotiable. Regulatory requirements are increasing at every step of a product’s life cycle and public scrutiny is intensifying.
ISO 13485 is the internationally recognized industry-specific standard for quality management systems. It is designed and intended for organizations involved in related to design and development, production, installation, servicing and sales of medical devices. A certified organization proves its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements.
Legal market access for products is essential for medical device manufacturers. National regulations often require ISO 13485 as part of the approval process for medical devices
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Related standard
- ISO 13485:2016 – Medical devices – A practical guide. This is an implementation guide authored by technical experts of ISO/TC 210 and published by the International Organization for Standardization (ISO). The handbook guides organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
- ISO 14971 – Application of risk management to medical devices. This standard specifies a procedure for manufacturers to identify hazards associated with medical devices and accessories and how to estimate and evaluate, control and monitor the identified risks as well as control effectiveness.
- ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems. This standard applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
Benefits of becoming certified
While beneficial for any manufacturer, ISO 13485 implementation and certification is a very good starting point for companies seeking to enter the medical device industry. In particular, certified companies can:
- Improve ability to contract with larger companies;
- Improve internal processes and decision-making;
- Create a culture of continual improvement;
- Demonstrate commitment to safety and quality;
- Prove ability to meet customer and legislative requirements.
Documents Required for ISO 22000:2018 Food Safety Management System Certification
Quality manual
Complaint handling procedures
Quality policy
Corrective and preventive action (CAPA) procedures
Risk management plan
Training procedures
Design control procedures
Internal audit procedures
Manufacturing procedures
Supplier control procedures
Why Choose Legal Dev for ISO 13485:2016 Certificate Service in India?
At KSP SOLUTIONS & ASSESSMENT PVT.LTD., we offer ISO 13485:2016 Certification to help medical device organizations comply with the international standard. Our team of experts has extensive experience in the medical device industry and can assist with every step of the certification process, from gap analysis to implementation and assessment.
Our ISO 13485:2016 Medical Device Certification Service includes a comprehensive assessment of your quality management system against the requirements of the standard, identifying areas that need improvement, developing and implementing a quality management system that meets the requirements of the standard, and conducting internal audits to ensure ongoing compliance.Our services are designed to help organizations achieve their quality objectives while saving time and resources