ISO 13485 is a standard for quality management systems specifically designed for manufacturers of medical devices and in vitro diagnostic medical devices. Compliance with ISO 13485 can help you fulfil regulatory requirements, manage risk and ensure the conformity of your product(s). By implementing a comprehensive QMS, you can ensure that your products meet the highest standards of quality and safety, and are effective for their intended use.

In addition, with the entry into force of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the European In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), it has become mandatory for manufacturers of medical devices and in vitro diagnostic medical devices to implement a QMS in accordance with Article 10 (MDR and IVDR), with ISO 13485 being the standard that best fulfils these requirements. The application of these regulations is mandatory for all manufacturers of medical devices and in vitro diagnostic medical devices who wish to place their products on the European Union market.

Our Regulatory Support Unit can help your company define and implement a Quality Management System in accordance with ISO 13485, including carrying out the first audits.

Implementing ISO 13485 can be a challenging process, but it is essential for manufacturers of medical devices and in vitro diagnostic medical devices to guarantee the safety and efficacy of their products, as well as regulatory compliance. If you already have a QMS in place in your company, to ensure that it complies with the requirements of Article 10 of the MDR/IVDR and ISO 13485, it is best to follow these steps:

1. Gap Analysis: Analysing your current QMS and comparing it with the requirements of ISO 13485 can be useful for identifying possible changes that need to be made to existing processes and procedures in order to comply with ISO 13485 and both regulations.
2. Developing an ISO 13485 Implementation Plan: Developing a plan to implement ISO 13485 based on your Gap Analysis will facilitate the process. This planning should include the timescales and resources needed to ensure a successful implementation.
3. Assignment of Roles and Responsibilities: Assigning specific roles and responsibilities to particular employees and/or teams ensures the effective implementation and maintenance of the ISO 13485 system.
4. Establish Procedures: Develop new procedures or review existing ones to ensure that they fulfil the requirements of ISO 13485. This point also refers to important processes such as documentation control, design and development and risk management.
5. Implement Procedures: Once established, new or revised procedures must be implemented. This includes training employees on the new/revised procedures to ensure that they are implemented and maintained in accordance with what is defined in the QMS.
6. Monitoring the effectiveness of the QMS: The effectiveness of the QMS is monitored by following process performance indicators and carrying out internal audits.
7. Continuous Improvement: Continuously improving your QMS by identifying opportunities for improvement and implementing changes is important for maintaining the conformity of the product(s).

The regulatory support unit can help your company adapt its QMS to the requirements of ISO 13485 and associated regulatory requirements, including carrying out audits.