Are you stuck when it comes to auditing your regulatory compliance or your management systems? Do you feel overwhelmed by the complexity of the tasks, do you simply lack the time, or are you struggling to convince your colleagues or superiors of the necessity of certain processes?
The implementation and maintenance of documents and management systems can be challenging – especially when this could lead to negative consequences such as non-conformities in external audits, which could even result in the loss of your certification.
Audits of management systems are the yardstick for measuring the maturity of your organisation. Whether it's an internal audit, supplier audit or certification audit, we not only check against the standard, but also identify potential improvements that will help your company move forward
We audit management systems according to the following standards
Our certified auditors have years of experience from notified bodies and certification organisations. We know both sides of the audit table and know what matters. With us, you receive objective assessments, constructive feedback and concrete recommendations for action – not theoretical lists of deficiencies.
Regulatory audits are high-risk situations. An MDR audit by the notified body, an FDA inspection or a routine audit by the authorities – the outcome determines market access and the continued existence of the company.
We audit according to the following regulatory requirements
Our regulatory auditors specialise in the critical assessment of your compliance. We conduct audits that are more rigorous than those carried out by the authorities – so that you are fully prepared. Thanks to our international auditing experience, we are fully aware of the expectations of various regulatory authorities and notified bodies.
Even after an external audit, we support you in analysing the causes and formulating targeted measures to solve the problems sustainably and to the satisfaction of the auditors.
We will accompany you during your upcoming system or process audit by a notified or certification body and ensure that everything runs smoothly.
We are familiar with all products, technologies and management systems in the medical technology sector and can carry out tests based on a wide range of regulations and standards. These include, for example, ISO 13485, ISO 9001, ISO 15189, ISO 27001, MDSAP and 820 CFR.
Our experts have not only successfully set up several hundred management systems for a wide range of manufacturers and their suppliers and guided them safely through the certification process. Our team consists of many experienced auditors who regularly train employees of notified bodies and some of whom are even active in standardisation committees themselves.
Our team of experts advises and supports you in all your tasks – from planning an internal or external audit to its implementation or support and follow-up. We provide you with tailor-made solutions for your individual challenges.
We provide you with an external perspective on your processes. We help to ensure that your management system and all associated processes are accepted and embraced within your company.
You will be communicating with a German-speaking person. They will coordinate the entire project and ensure that you do not create redundant QM or approval documents. This saves you time and money.
As your external Quality Management Representative (QMR), we take a lot of the QM work off your hands. This gives you continuity and regulatory certainty.
Save yourself the expense of setting up your own QM system and come under our QM umbrella. We also act as your legal manufacturer. This means your products can be brought to market as quickly as possible.
Want to expand your knowledge? Our tailor-made e-learning courses, seminars and workshops are the key.
So far, our experts have successfully set up several hundred management systems for a wide range of manufacturers and their suppliers and guided them safely through the certification process. Many of our auditors regularly train employees of notified bodies and some are themselves active in standardization committees, ensuring that they are always up to date with the latest requirements.
With our external perspective, you can identify potential and opportunities for improvement in your processes more clearly and at an earlier stage. We promote open communication between all parties involved and ensure that your management system not only exists on paper, but is actively implemented within the company. This fosters a corporate culture in which quality, cooperation, and continuous improvement are a matter of course.
If a standard or regulation according to which you would like an audit is not explicitly listed, please feel free to contact us anyway. We will then check whether we can accommodate your request.
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+1 (240) 638 27 09
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Our experts will help you establish a streamlined QM system that complies with ISO 13485 without the frustration of bureaucracy.
Our team will help you to effectively protect your data and meet the requirements of ISO 27001 with a streamlined information security management system.
We help you to efficiently integrate your management systems, e.g. in accordance with ISO 13485, ISO 9001 or ISO 27001, while saving costs.
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