Risk managers have a stressful job. The speed and ease with which devices are approved depends largely on their work. They are also held responsible for the safety of the devices.
If something goes wrong, it can lead to far-reaching problems that not only affect their own reputation within the company but can also damage the company's reputation in the market.
Our experts ensure that your devices are safer. That means less stress and fewer problems for you with reportable incidents and recalls that could damage your reputation.
No need to worry about file audits – with our experts at your side, you are well prepared for any audit and review and avoid unnecessary
non-conformity corrections.
With us, creating your risk management file is a breeze. This way, you can impress with quick results and your company with safe devices that quickly succeed on the market.
Our experienced experts know all the regulations and suitable methods like the back of their hands. With us, you only get proven concepts that really work in practice.
Our more than 100 experts are also available to help you with other topics as needed, such as biological safety, IT security, or the clinical evaluation of your medical devices.
You benefit from various templates that have proven themselves countless times in audits and reviews. That puts you on the safe side and saves you time and money.
Definition of suitable risk acceptance criteria
Systematic identification and evaluation of hazards as part of risk analysis
Definition of suitable risk control measures
Review of your existing risk management processes and identification of potential areas for improvement
Support in creating individual reports and documents, such as the risk management plan
Creation of the entire risk management file
Review of your existing risk management file for compliance with ISO 14971 and, if applicable, other standards, guidelines, and laws and provision of targeted suggestions for improvement
Help to process received deviation reports
Contact us now to find the best risk management strategy together.
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+49 7531 94500 20
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Our e-learning platform offers a flexible way to learn how to comply with regulations whenever and wherever you want.
Our customized seminars and workshops offer you the latest and tried and tested knowledge on specific topics firsthand.
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