ISO 27001 for medical device manufacturers
The medical device sector is responsible for the design and manufacture of a huge range of products used to diagnose, treat and monitor illnesses and diseases. This dynamic and important sector improves the health of millions of patients every year. It is well known for its innovative product development. Products range from diagnostic equipment to treatment equipment which includes artificial implants such as dental or hip replacements. The sector is huge and is becoming increasingly important for healthcare around the world and is an influencer on health expenditure.
Why medical device manufacturers should consider implementing a management system certification.
Several management systems certification standards are relevant to medical device manufacturing. The standard which is seeing a recent high uptake is ISO 27001 - information security management systems. This is due to medical devices becoming more sophisticated such as connected devices in the diagnostic room combined with greater public awareness. As a result, cyber security is an increasing concern.
Managing risk in medical devices seeks to minimize risk of harm to patients and colleagues. So how does this apply to data? Risk arises with possible security breaches, either through data integrity corruption or from lack of availability of data when it is called upon. Understandably privacy is of great consideration to the medical sector. ISO 27001 helps provide a systematic approach to the management of information security thereby minimizing risk.
ISO 27001 is based on a set of internationally recognized best practices that are not specific to any one platform or medical software package. Implementing ISO 27001 certification will enable you to adapt accordingly to cyber threats and to maintain continuity in the event of a cybersecurity incident.
The certification process means that you will have your security management systems independently assessed and audited by an accredited certification body to ensure that the management system meets the requirements of the standard. This process achieves an independent, expert assessment of whether you have implemented adequate measures to protect your patient’s data.
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