Služby
Co pro vás mohu udělat
IVDR is complex and unforgiving. Whether you are launching a new IVD, transitioning a legacy portfolio, or stuck in a Notified Body review cycle, I work hands-on rather than handing you a report and leaving. I bring proven documentation frameworks and practical automation that fits the tools you already use.
I work primarily with IVD manufacturers of every size, with startups and spin-offs building their first device, and with clinical laboratories operating within the European regulatory framework or approaching it seriously as a priority.
Projekty certifikace IVDR
Hlavní služba. The full certification journey for new IVD products and legacy device transitions, from the initial regulatory strategy through Notified Body submission and all the steps that follow once the certificate is issued.
- Analýza určeného účelu a klasifikace
- Regulační strategie a řízení projektu
- Technical documentation core document and the structure of the full dossier, so the submission is complete and navigable
- Vytváření technické dokumentace (PEP, PER, SVR, GSPR) a podpůrných šablon
- Strategie odevzdávání dokumentace, příprava a správa zpětné vazby oznámenému subjektu
- Příprava a vydávání prohlášení o shodě EU (DoC)
- Kontrola marketingových materiálů, značení a informací na webových stránkách z hlediska souladu s předpisy
- Registrace v národních databázích a EUDAMEDu
- Zajištění zahájení sledování po uvedení na trh a plnění plánů PMPF od prvního dne
- Správa portfolia starších prostředků (legacy devices) podle IVDR
Looking for a self-paced introduction first? See my online workshops and courses.
Notified Body Selection
Choosing the wrong Notified Body can cost you a year. Fewer than twenty are designated for IVDR across the whole of Europe, their designation scopes differ, and their capacity is finite. The quality of your first contact decides whether you get a slot or a waiting list.
- Shortlisting bodies actually designated for your device classes, codes, and conformity route
- Requesting and comparing quotations from several bodies, on timeline as well as price
- Structuring how products are distributed across certificates, which materially changes the cost
- Preparing and lodging the application, and handling the exchange until it is accepted
How products are grouped across certificates is a decision worth making deliberately rather than accepting the first proposal, and it is easier to get right before the application than afterwards.
Řízení zpětné vazby pro oznámené subjekty
Uvízli jste v cyklu přezkoumávání? Zpětná vazba od NB je často mnohem méně jasná, než byste si přáli. Pomůžu vám pochopit, co oznámený subjekt skutečně vyžaduje, a připravím přesné, technicky správné odpovědi, které problémy vyřeší, místo aby posuzování prodlužovaly.
- Interpretace zpráv NB o nedostatcí a objasnění skutečných požadavků, které za tím stojí
- Identifikace hlavních příčin nedostatků v technické dokumentaci
- Vypracování formálních odpovědí a revidovaných dokumentů
- Strategické zaměření odpovědí pro dosažení co nejlepšího výsledku
I would always rather be involved before the first submission. Catching a problem early is far cheaper than resolving it in review.
Interim Capacity When the Load Peaks
Sometimes the problem is not competence but capacity. Your team knows exactly what needs to happen and is already fully committed to work nobody else can take over: documentation content, analytical and clinical studies, data, instructions for use, document control, QMS activities, postmarket and customer care.
What is missing differs from company to company. Sometimes it is extra brains and hands on the documents. Sometimes it is project management to a fixed date, coordination across regulatory, R&D and sales, or simply someone who knows where the older documentation actually sits. In a narrow window that layer cannot be added internally without the specialist work suffering, and hiring takes months you may not have.
I can cover a good part of it for as long as it is needed: a transition wave, a submission peak, a parental leave, or the months before a permanent hire arrives. No onboarding time, and I leave behind templates and a process your team runs on its own next time.
Fast Track for Larger Portfolios
Registrace EUDAMED XML pro prostředky IVD
Registering your IVDs in EUDAMED does not have to be a weeks-long ordeal. This is a complete service, not a file conversion: it ends when your devices are actually registered.
What the setup fee buys. A working session where we go through your portfolio and agree how the data will be assembled, which system each field comes from, and how your identifiers, labelling and technical documentation need to line up. My detailed Excel template. Support while your team fills it in. A review of the completed data before anything is uploaded, so errors are caught on a spreadsheet instead of inside a database record. The XML build, the upload, and confirmation that the registration went through.
- 999 EUR setup fee covering up to 5 UDI-DIs, then 6 EUR per additional UDI-DI
- Rychlé zpracování od vyplněného Excelu po dokončenou registraci v EUDAMED
- Po dokončení procesu můžete své produkty zpracovávat přímo v EUDAMEDu.
It applies to IVDs under the IVDR and to legacy IVDs alike. For repeat batches, once the setup is done and your data structure is agreed, the setup fee can be reduced by agreement. V současné době k dispozici pouze pro prostředky IVD. A version for medical devices is in development. If that would be useful for you, get in touch and I will let you know when it is ready.
Technical Documentation and Clinical Documents
Jednotlivé dokumenty vytvořené samostatně nebo jako součást certifikačního projektu. Pro ostatní součásti technické dokumentace mohu připravit cenovou nabídku na základě vaší konkrétní situace.
- Technical documentation core document and a structure for the full dossier, so the submission holds together as one file rather than a folder of parts
- Three ways to run it: I set the strategy and your team writes, I manage the submission end to end, or I write the documents myself
- Plány a zprávy o hodnocení funkční způsobilosti (PEP a PER)
- Zprávy o vědecké platnosti
- Analytical and clinical performance reports
- Analytical and clinical performance study protocols and study reports
- Klinické důkazy a plány sledování po uvedení na trh
- GSPR checklisty
- Přezkum a sladění dokumentace o řízení rizik s hodnocením funkční způsobilosti, návodem k použití a aktivitami po uvedení na trh
Soulad s IVDR ve vašem systému managementu kvality
The deadline for IVDR QMS integration has passed. I help you check whether your existing Quality Management System truly meets what is expected under IVDR: reviewing procedures, SOPs, templates, and workflows against a structured gap analysis, then drafting the specific changes needed in each affected document.
The aim is a system that holds up in an audit and that your team can realistically maintain afterwards, not process added for its own sake. For small companies I look for the sweet spot: compliant but lean.
Poradenství a strategické konzultace
Strategické poradenství pro výrobce, startupy a klinické laboratoře v jakékoli fázi vývoje. Pomáhám objasnit regulační požadavky, identifikovat nedostatky a činit informovaná rozhodnutí, než přinesou zbytečně vysoké náklady.
- Plány dodržování předpisů a analýzy nedostatků pro výrobce IVD a malé a střední podniky
- In-house IVD pro klinické laboratoře: použitelnost IVDR a způsoby dodržování předpisů
- RUO and general laboratory use products: understanding IVD boundaries and available options
- Další názor před předložením dokumentů NB
International Registrations
Market access outside the EU for products that already carry a CE mark, including scope clarification, cross-department coordination, communication in English with local partners, and unblocking registrations that have stalled.
Territories worked on include European countries outside the EU, the Middle East, South America, and Asia. What I bring is the dossier and the coordination, working alongside your local distributor or registration partner who knows the national procedure.
PPWR Templates for Packaging
Regulation (EU) 2025/40 has applied since 12 August 2026. Packaging needs its own technical documentation and its own EU declaration of conformity, separate from your device DoC, and the obligation often sits with the company whose brand is on the box rather than with the packaging supplier.
I do not consult on packaging compliance in depth. What I offer is a practical starting point: a short guide and ready-to-fill templates in eight European languages, so your team can produce the documentation without beginning from a blank page.
Automation Without New Software
Templates that populate themselves from a single product data source, built inside the tools you already own. No subscription, no new platform, no vendor to onboard.
For a family of devices or a legacy portfolio, this is usually where the real time saving sits: consistent documents, fewer transcription errors, and fast updates when a requirement or an intended purpose changes. I always encourage manufacturers to use what they already have in place and keep the approach compliant but minimalist.
Smluvní a dočasné pozice
Need regulatory and clinical affairs capacity during a transition, peak workload, or key project? I step in as a solo interim RA/CA specialist, leading submissions, audits, and performance evaluation activities, and training your internal staff as we go.
Training for Your Team
Self-paced online courses, and live sessions built around your own portfolio and your own open questions. Topics delivered before include IVDR in general, IVDR for R&D, IVDR for sales and marketing, distributor and importer obligations, RUO versus IVD boundaries, certifying products under Notified Body surveillance, and clinical studies for IVDR certification.
Scope
Where I Hand Over
Being clear about this saves us both time.
- MDR strategy and advisory. I work under IVDR. I do not advise on regulatory strategy for medical devices, and for that I will point you to someone who does. Where the format and expectations for a document are already settled, I can work on the writing itself.
- Building a QMS or a risk management system from scratch. I review, refine, and close gaps in what you already have. For a full build, I work with trusted independent specialists.
- EU Authorised Representative. Not a service I offer.
- Laboratory work and legal opinions. My background is in molecular biology, but I no longer hold a pipette and I have no laboratory of my own. Analytical and clinical performance measurements sit with your laboratory or with a specialist provider, and I will tell you when you need one. Clinical performance studies are a different matter: where you take on the sponsor role, I support the documentation, the protocol and the reporting around the study.
- Markets. IVDR and the EU market are the core. For European countries outside the EU, the Middle East, South America, Asia, and other markets outside the EU, I support registration of IVDs that already carry a CE mark, not full local regulatory strategy.
Where a project runs under a grant or subsidy scheme, I can deliver the consulting work in the form the scheme requires, including a structured final project report documenting the outputs.
Not Sure Which One You Need?
That is what the discovery call is for. Thirty minutes, free, no obligation. You will leave with a concrete next step whether or not we end up working together.