Due to their physical properties, manufacturers of electrically operated medical devices must demonstrate that these do not pose a hazard to patients, operators, or third parties. The devices must be safe, effective, and provide the intended clinical benefit. That is usually demonstrated by applying technical standards, such as IEC 60601-1 or IEC 61010-1.
However, many of those responsible are unclear about which regulatory requirements they must meet, how the standards are to be applied correctly, and what documentation is required to avoid deviations and problems during device approval.
With our support, you are in safe hands.
There is no need to sweat when file reviews are pending – with our experts at your side, you are well-prepared for any audit or review.
You can sit back and relax: Our team will take over the entire project management if necessary – from development support to the organization of the required tests to the final file.
With us, creating your documentation becomes a sprint. This way, you can shine with quick results, and your company will have safe devices that quickly succeed in the market.
Our medical device experts know all the regulations inside and out. They’re even involved in the process when new standards are being drafted, so they know exactly how to do everything right.
Our team of over 100 experts can also assist you, if needed, with the preparation of additional documents as part of your technical documentation, such as the risk management dossier or biocompatibility dossier.
You’ll benefit from templates that have proven their worth countless times in audits and reviews. This ensures you’re on the safe side while also saving time and money.
We help you determine the relevant standards and applicable requirements.
We check your existing data and documents for conformity with standards, guidelines, and laws and provide you with targeted suggestions for improvement.
We create your complete documentation if required.
We help you with questions from auditors and investigators.
We answer your individual questions in an interactive workshop, no matter how big or small the issue.
We create individual reports and documents, such as the proof of the essential performance characteristics, the isolation diagram, or the safety concept.
We check system and security architectures for single-fault safety.
Contact us to discuss how you can quickly and easily obtain legally compliant documentation.
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+1 (240) 638 27 09
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Do you still need to perform safety and EMC tests? We would be happy to support you, e.g., in creating test plans and selecting test houses.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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