For medical device manufacturers a quality management system is a regulatory requirement, but there is nothing in any of the regulations or standards that dictates how the system should look. A company should interpret the requirements of the regulations and standards for itself and design a quality management system that both satisfies the applicable requirements and which makes sense for their operations.
ISO standards assume that a business has defined its operations based on a number of processes. ISO 13485 is the standard that is harmonized with the EU regulations for medical devices. Harmonization means that ISO 13485 is consistent with the quality system requirements contained in the EU’s medical device regulations. Applying the ISO 13485 standard is therefore a step towards fulfilling the regulatory requirements for quality systems.
An ISO certification is different from CE certification. CE marking is a certification on the product level and is required for entry into a new market, while an ISO certification is a certification at the company level and not a requirement for CE marking.
ISO 13485 is not only harmonized with EU regulations, but it also makes reference to regulations in, for example, Canada, Japan, China and Australia. Although the regulatory requirements on quality systems are imposed on the responsible manufacturer, all suppliers to medical device manufacturers also need to have quality systems. To certify operations by the ISO 13485 standard is a major competitive advantage that shows that the supplier is qualified and meets the requirements of medical device manufacturing.
Equivalent requirements for the quality management system in the US are contained in regulation 21CFR820 and are called QSR (Quality System Regulation). Overall, the requirements are the same in the QSR and ISO 13485, but there are significant differences that must be considered and managed.
What Symbioteq can do
Symbioteq has extensive experience in developing, implementing and streamlining quality management systems. We are well acquainted with both the regulatory requirements in the EU and in the rest of the world, and with the relevant standards (ISO 13485, ISO 9001) such as process mapping and business development. Having this combination means that we can help you develop a quality management system that both ensures that regulatory requirements are met and which will lead to significant benefits for your business.
You decide how much support you need. We can help you with everything from project managing a development/improvement project to providing support to individual processes/procedures. We can also conduct internal audits. Examples of common tasks include:
- Developing a management system (compatible with ISO 13485, ISO 9001, QSR, etc.)
- Facilitating process mapping
- Conducting gap analysis to identify both the shortcomings in compliance as possible improvements
- Updating the management system to satisfy requirements for the QSR
- Support with individual processes and procedures
- Business analysis with a view to streamlining the work of the quality management system
- Support with the development of procedures in connection with the CE marking
- Internal audits
- Training in quality systems and the relevant requirements
Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry