![[Translate to English:] Analyse von Dokumenten auf einem Tisch im Büro](/fileadmin/user_upload/Header_1200x230_Document_Check_Meeting-opt.jpg)
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.
We review your entire (management) system and the associated specification documents as part of an internal or mock audit. In doing so, we proceed according to the processes you specify.
We review your compliance in the form of a procedure or process audit. We are also happy to conduct an audit of your suppliers.
We provide you with tailor-made audit plans based on your internal audit criteria.
We provide you with templates for audit reports, help you write them, or review your reports as part of a gap analysis.
Our tailor-made audits offer much more than standard-compliant evaluations. They are a tool for increasing the efficiency and compliance of your business processes. Whether management system audits, regulatory compliance, specific national requirements or technical standards – we offer you a detailed review and suggestions for improvement by experienced auditors with industry-specific expertise.
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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.
![[Translate to English:] Dokumente werden analysiert](/fileadmin/user_upload/Side_Photo_520x290_Document_Analysis_Table_only_Hands-opt.jpg)
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.
![[Translate to English:] Menschen analysieren Nationale Vorgaben](/fileadmin/user_upload/Teaser_Photo_775x380_People_Analyzing_Documents.png)
National regulations are often underestimated – until the audit. Our country experts audit your local compliance with the detailed knowledge that only insiders have. We not only check documents, but also the practical implementation of national specifics.
We audit according to the following national requirements
From reviewing your safety officer structure in accordance with MPGD to evaluating your vigilance processes in accordance with national implementations, our audits uncover the gaps that international auditors often overlook. We also take into account regional interpretations by authorities and unwritten expectations.
![[Translate to English:] Usability-Prozess wird geprüft](/fileadmin/user_upload/Side_Photo_520x290_Usability_Study_Laboratory_Observation.png)
Technical audits require specialist knowledge. Our specialist auditors are not only standards experts, but also experienced engineers who understand the technical background. We check the application of technical standards where it matters: in development, production and in the testing laboratory.
We audit according to the following technical standards
We audit on an equal footing with your technical teams. In doing so, we identify not only deviations from standards, but also risks and potential for optimisation in your technical processes.
We will accompany you during your upcoming system or process audit by a notified or certification body and ensure that everything runs smoothly.
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.
![[Translate to English:] Frau blättert im Büro in Dokumenten](/fileadmin/user_upload/Side_Photo_520x290_Audit_Situation-opt.jpg)
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.
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 provide this service.
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+49 7531 94500 20
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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.
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.
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