Compliant. Consistent. Aligned with the expectations of Notified Bodies.
International Market Access
Strategic from the start
Planning for international market access early helps optimize timelines, control costs, and improve market success. Those seeking to reach global markets must consider Regulatory Requirements from the outset. We support manufacturers of medical devices and in vitro diagnostic medical devices with international market access strategies – not over-regulation, not theory, but solutions that are regulatory, economically viable, and scalable.
Approved once is not enough – and considered once is not enough either.
International market access is not an isolated project at the end of product development. It is part of the growth strategy. We consider regulatory requirements, existing documentation, and target markets in context – so that international expansion enables rather than hinders progress.
What we cover internationally
International Market Access & Regulatory approval strategies
- Your target markets, regulatory pathways, and timelines are clearly prioritized and aligned with your business objectives
- International regulatory approval is part of your growth strategy – not an isolated compliance project
- You receive a realistic and economically sensible basis for decision-making – also for management and investors
Transfer of MDR/IVDR documentation to international requirements
- Existing documentation is structured and made usable for international target markets – without redundant rework
- Clinical data, test reports, validations, and QM processes are strategically reused
- Additional effort and unnecessary costs are avoided through structured reuse
USA – FDA strategy & regulatory preparation
- Den US-Marktzugang haben wir in einem eigenen Leistungsbereich ausgearbeitet – von der FDA-Strategie über Submission Readiness bis zur dauerhaften Marktpräsenz
→ US-Marktzugang
Support with implementation & regulatory coordination
- Regulatory coordination is managed – you have a reliable contact through to implementation
- Strategy and reality remain aligned – even when requirements change
Permanently compliant – without additional effort
- Einmal zugelassen bedeutet nicht dauerhaft konform. Internationale Anforderungen ändern sich – Vigilanz, PMS und Regularien weltweit. Mit dem Update Service von regular services bleibt Ihr System laufend aktuell und auditbereit
→ Mehr zu unseren Update Services
International market access does not have to be complicated.
We’ll help you set the right course right from the start – clearly, practically and in a way that’s compatible with international standards.
Kostenfreies Erstgespräch vereinbarenWhen manufacturers come to us
MDR/IVDR certification in place
Additional markets such as USA, UK, or Asia are to follow in a structured and efficient manner.
Early planning
International requirements are to be incorporated into development and documentation from the start.
Decision basis needed
Management or investors need a clear, realistic market access strategy, including an estimate of the regulatory effort.
Our services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about international market access
No. CE Marking according to MDR or IVDR applies exclusively to the European market and is not recognized by the FDA. A separate approval procedure is required for the US market – 510(k) Submission Process, De Novo Submission Process, or Premarket Approval, depending on the product and Risk Class. However, many pieces of evidence from the EU can be used as supporting documentation, provided they meet FDA requirements. This saves time and costs – if planned correctly from the start.
MDSAP (Medical Device Single Audit Program) ist ein internationales Auditprogramm, das QMS-Anforderungen der fünf teilnehmenden Länder USA, Kanada, Brasilien, Japan und Australien in einem einzigen Audit zusammenfasst. Ein erfolgreiches MDSAP-Audit kann den Marktzugang in allen teilnehmenden Ländern erleichtern und ist für den kanadischen Markt (Health Canada) verpflichtend. Wir bewerten, ob MDSAP für Ihre Marktstrategie sinnvoll ist.
MDSAP-Anforderungen sind direkt in unserem QM-System abgebildet – für Hersteller mit internationaler Ausrichtung ein effizienter Ausgangspunkt.
→ QM-System mit Update Service
In many cases, yes – if it is structured for this purpose from the start. clinical Data, Risk Management Files, test reports, and QM processes can be strategically reused for international requirements. Duplication of effort arises primarily when international requirements are
As early as possible – ideally in parallel with European approval. Addressing international requirements only after CE Marking often results in duplicated effort. Early planning saves time, reduces costs, and prevents documentation from needing to be recreated. We develop a realistic international roadmap with you – aligned with your product and business strategy.
Yes – since July 2025, manufacturers with EU approval under MDR or IVDR can use a simplified approval procedure with COFEPRIS. Technical Documentation, Notified Body Conformity Assessment, and Clinical Evaluation are accepted – a separate review by COFEPRIS is not required. The theoretical review period is 30 working days. Important: the Mexican partner becomes the marketing authorization holder, so careful selection is essential. Manufacturers who have already brought their MDR documentation up to date can access the Mexican market with comparatively little additional effort.
We’ll help you set the right course right from the start – clearly, practically and in a way that’s compatible with international standards.