Software used in a medical context has long been more than just a technical tool.
It not only provides medically relevant data, but also provides targeted support in decision-making, structures therapeutic processes and enables potential risks to be identified at an early stage.
And although there are qualitative differences in the purposes for which medical software solutions are used, the same standards apply to them as to traditional medical devices - and rightly so.
The requirements? Challenging.
The room for manoeuvre? Must be utilised.
The expectations? Of course.
TentaConsult Pharma & Med GmbH has been supporting companies in the clinical evaluation of their medical devices for many years - and also offers this service for medical software. With a clear focus on the essentials and a profound understanding of what really counts from a regulatory perspective.
Regulation needs relevance - not text modules!
The focus is on a well-founded analysis of the intended software functions in the application context and their significance for the product classification - right through to the development of a viable clinical evaluation strategy (such as the WET route or equivalence route). Whether based on own study data, relevant literature or in the context of an equivalence argumentation - TentaConsult carries out the entire process up to the preparation of a clinical evaluation report. We support you in every phase of the process and use our many years of experience to fulfil the regulatory requirements and the expectations of the notified bodies with regard to the quality of a clinical evaluation for software.
This is because, as with any other medical device, the clinical evaluation of medical software is not a tedious compulsory part, but the decisive proof that the medical device is suitable, efficient and safe for its intended purpose. In contrast to other medical devices, medical software often involves a new level of complexity that poses particular challenges for manufacturers.
But where is technical data sufficient - and where is meaningful clinical data required to ensure patient safety? Is quantitative data required or is a qualitative description sufficient?
TentaConsult Pharma & Med GmbH is a reliable partner for manufacturers - with expertise, methodological clarity and a trained eye for regulatory pitfalls. If desired, we can also take over communication with your notified body, "translate" the regulatory requirements and navigate you through this jungle, which is often opaque for software developers.
More information and a first non-binding exchange:
www.tentaconsult.com or directly via info@tentaconsult.com
About TentaConsult Pharma & Med GmbH
TentaConsult, based in Münster, is a consulting company specialising in the life sciences sector. The company offers regulatory consulting, quality assurance and assumption of responsibility for medicinal products, medical devices, combination products, food supplements and cosmetics.
As part of the Tentamus Group, TentaConsult works closely with international laboratories and partner companies throughout the entire product development and authorisation process.
It not only provides medically relevant data, but also provides targeted support in decision-making, structures therapeutic processes and enables potential risks to be identified at an early stage.
And although there are qualitative differences in the purposes for which medical software solutions are used, the same standards apply to them as to traditional medical devices - and rightly so.
The requirements? Challenging.
The room for manoeuvre? Must be utilised.
The expectations? Of course.
TentaConsult Pharma & Med GmbH has been supporting companies in the clinical evaluation of their medical devices for many years - and also offers this service for medical software. With a clear focus on the essentials and a profound understanding of what really counts from a regulatory perspective.
Regulation needs relevance - not text modules!
The focus is on a well-founded analysis of the intended software functions in the application context and their significance for the product classification - right through to the development of a viable clinical evaluation strategy (such as the WET route or equivalence route). Whether based on own study data, relevant literature or in the context of an equivalence argumentation - TentaConsult carries out the entire process up to the preparation of a clinical evaluation report. We support you in every phase of the process and use our many years of experience to fulfil the regulatory requirements and the expectations of the notified bodies with regard to the quality of a clinical evaluation for software.
This is because, as with any other medical device, the clinical evaluation of medical software is not a tedious compulsory part, but the decisive proof that the medical device is suitable, efficient and safe for its intended purpose. In contrast to other medical devices, medical software often involves a new level of complexity that poses particular challenges for manufacturers.
But where is technical data sufficient - and where is meaningful clinical data required to ensure patient safety? Is quantitative data required or is a qualitative description sufficient?
TentaConsult Pharma & Med GmbH is a reliable partner for manufacturers - with expertise, methodological clarity and a trained eye for regulatory pitfalls. If desired, we can also take over communication with your notified body, "translate" the regulatory requirements and navigate you through this jungle, which is often opaque for software developers.
More information and a first non-binding exchange:
www.tentaconsult.com or directly via info@tentaconsult.com
About TentaConsult Pharma & Med GmbH
TentaConsult, based in Münster, is a consulting company specialising in the life sciences sector. The company offers regulatory consulting, quality assurance and assumption of responsibility for medicinal products, medical devices, combination products, food supplements and cosmetics.
As part of the Tentamus Group, TentaConsult works closely with international laboratories and partner companies throughout the entire product development and authorisation process.
