ISO 13485:2016

ISO 13485:2016 Medical Devices Quality Management System Certificate

The ISO 13485 standard is a good way to meet all of the standards for a medical device quality management system. A medical device is a product, such as an instrument, machine, implant, or in vitro reagent, that is used in the diagnosis, prevention, and treatment of diseases, illness and disease rehabilitation, or other medical situations. Adherence to ISO 13485 provides a solid framework for manufacturers to satisfy Medical Device Directives, rules, and duties while also demonstrating a commitment to medical device safety and quality.

What does ISO 13485 stand for?
ISO 13485 is the most frequently used international standard for quality management in the medical device industry. The ISO 13485 standard, developed by the International Organization for Standardization (ISO), is an effective way to meet the entire requirements for a QMS in the medical device business. Adopting ISO 13485 gives manufacturers a realistic foundation for addressing the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other legislation, as well as demonstrating a commitment to medical device safety and quality.


The ISO 13485 standard specifies standards for the production, installation, and maintenance of medical devices, with a special emphasis on conformity with EU Directives for MD or IVD, such as:

• Technical documentation (medical device file/technical product file) is provided.
• Requirements for design and development
• Implementation of a risk management process in the product development and realisation process.
• Process verification.
• Requirements for health, safety, and staff cleanliness
• Change management, market research, and product recall procedures
• Observance of legal and regulatory obligations
• Product tracking and recall solutions that work.

Document Required For ISO Certification

The documentation required to comply with ISO 13485:2016 are listed below.

• Quality objectives and a quality policy.
• Medical Equipment Manual for the quality management system.
• Medical device process management must follow this procedure.
• Infrastructure and maintenance activities must meet certain requirements.
• Requirements for the workplace
• Control arrangements for tainted or possibly contaminated goods
• Risk management process in product development
• Procedures and records for medical device servicing, as well as service validation.
• Data analysis and corrective action procedures and records

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