A seminar explains the IVDR to you. This workshop answers the question that remains afterwards: what does it mean specifically for your product? Together with our expert, over one to two days you develop a performance evaluation strategy for an IVD of your choice – based on your own documentation, not on someone else's examples.
1–2 days
max. 10 participants
In-house at your site
A performance evaluation can't be copied from a template. Which performance parameters count, which you may justifiably leave out, which evidence the Notified Body expects – that depends on your intended purpose, your measurement principle and your data. It's exactly this step – translating the IVDR requirements onto your own product – where many teams get stuck.
A clear process in four steps – prepared on your product, not on a textbook example.
You provide your documentation – intended purpose, product description, state-of-the-art research and, where applicable, the instructions for use. Our expert studies your product beforehand.
We clarify which analytical and clinical performance parameters are relevant for your IVD – under the IVDR and relevant guidance such as MDCG 2022-2 – and where non-applicability can be justified transparently.
We derive initial product-specific evidence strategies and plan selected performance studies based on relevant CLSI guidelines – including the key points for your test and study concepts.
You leave the workshop with open points, dependencies and clear next steps for your internal detailed planning. An optional follow-up session deepens the further study planning.
Every point starts from your product – from reviewing your documentation to first viable study concepts:
We review the documentation you provide – intended purpose, product description, state-of-the-art research and, where applicable, the instructions for use.
Your benefit: The workshop starts from your product, not from scratch.
We assess which regulatorily required performance parameters under the IVDR apply to your IVD, taking into account relevant guidance documents such as MDCG 2022-2.
Your benefit: You know what counts – and what doesn't.
Where a performance parameter doesn't apply to your product, we derive a traceable justification – structured, rather than simply left out.
Your benefit: Fewer items of evidence, soundly justified instead of riskily skipped.
We develop initial product-specific evidence strategies for your IVD's analytical and clinical performance parameters.
Your benefit: A clear thread before study budgets are committed.
We plan selected performance studies initially based on relevant CLSI guidelines and show which items of evidence can sensibly be combined.
Your benefit: First viable test and study concepts.
We capture open points, dependencies and the next steps for your in-house detailed planning.
Your benefit: Clarity on what your team can take forward the next working day.
If needed, in an additional session we discuss your further developed study planning and resolve any remaining questions.
Your benefit: Depth exactly where you need it.
No more theory – but decisions you've made for your IVD.
You estimate the scope relevant to your product and avoid unnecessary effort.
You assess regulatory requirements product-specifically and apply them to your IVD.
You prepare first study and test plans in a targeted way – based on relevant CLSI guidelines.
You define the next steps for your internal detailed planning clearly and traceably.
There are three routes for the performance evaluation – depending on how much you want to do yourself. This workshop is the middle one.
You learn the principles of performance evaluation – in general and through examples, not on your product.
You develop the performance evaluation strategy for one specific IVD – yourself, with our expert, on your documentation. Including first study concepts.
We create your performance evaluation – from the state of the art through the strategy to a submission-ready file.
You leave the workshop with a product-specific performance evaluation strategy, first study concepts and clear next steps. The detailed development and in-house implementation stay with you – we provide the technical foundation and the direction.
We agree the exact scope in a free introductory call, tailored to your product and your data situation.
Our expert studies your product beforehand and develops the strategy together with you – on your intended purpose and your documentation. You keep the result, the responsibility and the implementation in your hands.
Develop the performance evaluation strategy for your product – over one to two days, with our expert. Start with a no-obligation introductory call.
Request the Workshop →In the introductory call we get to know your product, clarify the focus and agree the duration and participant group. Afterwards you receive a quote that fits your IVD. No obligation.
We'll be in touch shortly to schedule your introductory call.
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