In our day-to-day work, we receive numerous non-conformity reports from Notified Bodies and national authorities: a non-compliant or incomplete clinical evaluation results in enormous time pressure, high costs and, often, repeated rework for manufacturers. With the MDR’s transition periods coming to an end, the time available for corrections is becoming increasingly limited – the PMS, PMCF and clinical evaluation must be drawn up early, comprehensively and correctly.
Regulatory requirements and expectations regarding clinical evaluations are constantly increasing. In our consultancy practice, we repeatedly encounter the same stumbling blocks: unclear demarcations, a lack of state-of-the-art analyses, PMS or PMCF activities that are not coordinated in terms of content, and time-consuming, manual research. Many manufacturers invest a great deal of time and resources, work with unreliable templates – become entangled in endless rounds of corrections and, as a result, find themselves under time pressure.
Whether you wish to prepare your Clinical Assessment yourself, are seeking targeted support with updating or drafting a new one, or want to outsource the entire process relating to Clinical Assessment, PMS and PMCF: we offer you the right solution. Rely on structured support, up-to-date specialist expertise and tried-and-tested methods – for efficient results and maximum relief.
Whether you wish to develop it yourself or outsource the process entirely – you can benefit from our experts’ methodological expertise and up-to-date knowledge.
Structured processes and tried-and-tested tools enable results to be delivered within predictable timeframes.
You will receive structured results, clear recommendations and a clear overview of the next areas for action.
All services align with the requirements of the MDR, MEDDEV 2.7/1 Rev. 4, and relevant MDCG guidelines.
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Choose the package that best suits you and your situation – from guided self-implementation to full process outsourcing.
You will conduct your clinical evaluation independently, whilst benefiting from guidance, clear templates, personalised advice and a final review*:
Your benefit: you receive clear and practical support throughout the entire process – from the strategy workshop right through to the final optimisation of your documents.
Suitable for you if: you want to build up in-house expertise whilst relying on a structured process with expert guidance.
We take care of the complete preparation and/or updating of your clinical evaluation; systematic literature search included**:
Your benefit: You receive a complete clinical evaluation that meets all regulatory requirements – the ideal basis for authorisation, updates and planning of PMCF activities, without placing any additional burden on your team.
Suitable for you if: you wish to conserve resources and value a professionally prepared, up-to-date dossier.
We provide a comprehensive service covering the updating and creation of KBs, as well as the planning, research and preparation of relevant reports relating to PMS and PMCF:
Your benefit: We handle the entire process, including reviews and re-reviews, offer ongoing support and ensure that your clinical evaluation, PMS and PMCF are managed in a way that is always up to date, comprehensive and takes the pressure off you.
Suitable for you if: you are looking for maximum relief from administrative burdens, manage multiple products or wish to fully outsource routine regulatory processes
Together we determine which package best suits your needs. Let's talk!
Your dossier will be prepared by experienced specialists who closely integrate regulatory and medical requirements.
At the start of the project, we hold a joint kick-off meeting. Transparent planning, regular updates and close communication form the basis of the entire project.
To prepare the assessment, we require all relevant documents in advance, such as the product description, technical documentation, risk analysis and existing PMS/PMCF reports. We will agree on the exact list individually during the initial consultation.
Yes, we handle your data with utmost care and confidentiality. It is stored on certified infrastructure within the EU. You decide whether and when your documents are archived or deleted.
Yes, you can, for example, commission only the preparation of the clinical assessment, a literature review or an update.
For manufacturers with a larger portfolio, we offer structured solutions – with transparent processes, bundled support and dedicated contact persons.
In a short, no-obligation web conference, we’ll clarify your product details, the status of your documentation, your timeline and the model best suited to your individual needs.
Automate your post-market surveillance: We'll take care of the ongoing monitoring of relevant reports for your products.
We’ll help you develop an optimal clinical strategy so that you’ll know exactly what to expect during the clinical evaluation
Want to expand your knowledge? Our customized e-learning courses, seminars, and workshops will put you on equal footing with experts.
With our support, you can ensure the quality of your clinical trial or study and its results.
Our support doesn't end with approval. We're also here to assist you with post-market surveillance (PMS) and post-market clinical follow-up (PMCF).
*Prerequisite: All necessary documents must be complete and up to date at the start of the project.
**Prerequisite: All basic documents must be complete and up to date at the start of the project.
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