MedDev Regulatory (MDR) Consulting are experts in risk management activities and can help ensure that you remain compliant.
Once your medical device has been transferred into production, the risk management file must be regularly reviewed and kept up to date. ISO 14971 documents the requirements for the lifecycle process of any device marketed, including production and post-production information. A robust risk management procedure and appropriate training are important to facilitate the process and any additional required activities.
The current version of ISO 14971, is ISO 14971: 2019 for the application of risk management to medical devices, and companies must comply with its requirements. It is crucial that you follow the current version of ISO 14971, as failure not to, will be classed as not following the state of the art, resulting in non-compliance. If you are a medical device company following 14971: 2012, the transitional period for being able to claim compliance against the 2012 version has now passed.
MedDev Regulatory (MDR) Consulting is here to provide expert support and guidance with risk management activities. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.