Service Area
Legal Representation
We act as your global compliance partner, uniquely combining detailed MedTech knowledge with hands-on regulatory strategy.
Legal Representation
Accelerate time to market
As a MedTech company, you face a complex regulatory environment with legal challenges, from dealing with global registrations to protecting intellectual property. You must balance innovation with strict compliance and structure contracts with suppliers, manufacturers, and healthcare providers. Without local offices in each country, you must outsource legal representation in countries where you need market access. You can rely on your distributors; however, this comes with risk regarding your IP, and you limit yourself to 1 distributor.
With Qserve as your guide, we independently handle the legal and regulatory details through expert insights and hands-on execution. Acting as your Authorized Representative or Agent, we bridge legal obligations and regulatory demands, ensuring compliance and speeding up market approval.
Our expertise helps you align market approval with mandatory local legal representation. Doing it right the first time will accelerate time to market.
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Local expertise
Global reach
Transparant
Process, timelines and costs
One
Contact person
24/7
Regulatory Intelligence Platform
Companion Diagnostics (CDx)
Our Legal Representation services cover multiple disciplines. Discover them:
U.S. Agent
We act as your official U.S. FDA communication representative, streamlining submissions and regulatory responses for non-U.S. manufacturers.
European Authorized Representative (EAR)
As your EU AR, we ensure full compliance with EU MDR and IVDR, managing regulatory communications and documentation with notified bodies and authorities.We are the market leader in CE certification services.
UK RP
We support market access in the UK by fulfilling legal obligations post-Brexit and serving as your official UK regulatory contact.
Swiss AR
We enable Swiss market entry by acting as your local authorized representative under Switzerland’s evolving regulations.
China Agent
We facilitate regulatory approvals in China by acting as your in-country agent, bridging language, compliance, and regulatory gaps..
Global License Holding
We provide trusted global license-holding services, allowing companies to operate compliantly in regions requiring a local legal entity.
Clinical Investigations
We offer strategic support and legal representation throughout the MDR certification process, reducing delays and non-compliance risks.
Clinical Performance Studies
We handle the complex IVDR certification pathway with expert procedural support and legal standing, ensuring seamless EU market access for IVDs.
Legal representation is mandatory in all countries where you want to get market approval. It is essential to understand the details in each market. A clear plan will accelerate time to market.
We handle legal representation in many countries. We take care of things from end to end, including payments to local authorities and license-holding fees. With Qserve, you have one supplier and one-stop shopping.
Do you want to have the best service in class?
Legal representation is mandatory in all countries where you want to get market approval. It is essential to understand the details in each market. A clear plan will accelerate time to market.
We handle legal representation in many countries. We take care of things from end to end, including payments to local authorities and license-holding fees. With Qserve, you have one supplier and one-stop shopping.
Do you want to have the best service in class?
Legal Representation
FAQ
Couldn't find your question?
Why centralize legal representation and regulatory compliance?
You have centralized oversight if regulatory compliance and legal representation are in the same hands. Considering existing compliance documentation, this ensures that all legal and regulatory activities are aligned across one country.
What risks arise from unclear legal responsibilities?
There is no oversight of all country registrations, no renewal deadlines, and no knowledge of or action on regulation changes. This leads to inefficiency, which can cause delays in market access or loss of market share.
How does Qserve help reduce legal inefficiencies?
Qserve acts as a unified partner by offering services like EU Authorized Representative, UK RP, and global license holding. We ensure consistent compliance and efficient coordination across jurisdictions.
How to keep up with changes in regulations?
We use our own platform to scan international and local regulations for changes and updates. The regulatory intelligence platform works 24/7. We send you automated alerts if anything changes in your selected markets involving regulations, standards, guidance, and more.
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